audit checklist for store department
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Audit Checklist for Store DepartmentTRANSCRIPT
Audit Checklist for Store Department Sr. No.Check pointsObservationRecommendationAction taken by
01Is the control copy of store department SOPs available?
02Is the personnel having knowledge of current GMP requirements?
03Is the incoming raw materials entry register available?
04Is the housekeeping maintained?
05Is the sampling booth area cleaned?
06Is the weighting balance having proper tag of calibration status?
07Is the balance calibration record available?
08Are the calibrated standard weights available?
09Is the calibration certificate available?
10Is the standard weights are properly stored?
11Is the quarantine, approved and rejected area designated?
12Are the UNDER TEST label pasted on all the incoming raw materials?
13Are the SAMPLE label pasted on all the sampled raw materials?
14Are the APPROVED labels pasted on all the approved raw materials?
15Are the raw materials stored at their respective place?
16Check the cleaning and housekeeping condition record of quarantine, approved and rejected area.
17Are the packing materials stored separately?
18Is the cleaning and housekeeping maintained at packing material store area?
19Is the temperature and relative humidity record maintained for all respective area?
20Is the approved vendor list available?
21Is the FIFO system follow?
22Check the production requisition slip record?
23Check the issuance record.
24Check the dispatch record.
25Check the general cleaning and housekeeping of store.
26Check the personnel hygiene.
27Check the safety equipments.
28Check the drum storage yard for cleaning, housekeeping and status.
29Check the proper segregation at drum storage yard?
30Check the other records.
31Is line clearance activity performed?
You might also like: Self Audit Checklist for Maintenance Department Self Audit Checklist for Quality Control Department Self Audit Checklist for Production Department Internal Audit Plan as per GMP LinkWithin Posted by Quality Assurance and GMP and ICH at 12:56 PM 0 comments Email This BlogThis! Share to Twitter Share to Facebook Share to Google Buzz Links to this post Reactions:
Self Audit Checklist for Quality Control Department
Sr. No.Check pointsObservationRecommendationAction taken by
01Is the control copy of QC department SOPs available?
02Are the personnel having knowledge of current GMP requirements?
03Is the housekeeping maintained?
04Is the weighting balance having proper tag of calibration status?
05Is the balance calibration record available?
06Are the calibrated standard weights available?
07Is the calibration certificates available?
08Is the standard weights are properly stored?
09Are the status labels available on each instrument?
10Is the instrument calibration record available?
11Check the temperature and humidity record.
12Check the cleaning record.
13Check the cleaning of sampling devices.
14Are all the sampling devices properly stored?
15Check the general cleaning and housekeeping of QC.
16Are the specifications available for raw material, packing material, in-process samples, intermediates and finished products?
17Check the in-process testing record.
18Check the raw material testing record.
19Check the final product testing record.
20Check the stability record.
21Check the stability chamber record.
22Check the solution preparation and standardize record.
23Check the control sample record.
24Check all instrument log book.
25Check the primary standards and its storage.
26Check the mobile phase status of GC and HPLC.
27Check the HPLC column record.
28Check the test request slip record.
29Check the personnel hygiene.
30Check the safety equipments.
31Check the other records.
32Check the environment where control sample store?.
33Is log book of destruction of control sample is maintained?
34Is the out of calibrated instrument well labeled?
35Is QC Chemist validated?
36Is the sample in QC lab well labeled?
37Are the personnel following GLP?
38Are training given to new personnel?
39Are all QC personnel in proper dress code?
40Is glassware breakage log book maintained?
41Check DM water analysis record.
42Check reference standard records?
43Is proper sampling plan available?
Internal Audit Plan as per GMP
1.0 Purpose :This document describes the conduct of the Management review of the quality system for GMP Conformance Certification, including the conduct of an internal audit to assure the system meets the requirements of ISO Guidelines and is effectively implemented..2.0 Objective: To Provide Documented Procedure for review of the quality system for GMP Conformance Certification, including the conduct of an internal audit to assure the system meets the requirements.3.0 Scope : To define role/responsibility of various functions responsible for Internal audit4.0 Responsibility : o Board of Internal Audit and Management Review Committee: Arranges for the internal audit and gathers all information for the Management Review.o QA Management Committee: Provides all information as required by the Board of Internal Audit and Management Review Committee and is responsible for follow-up corrective and preventive actions.o QA Internal Auditor(s): Conduct the internal audit according to GMP.5.0 Procedure : The QA Management Committee, by consensus, selects three qualified individuals for the Board of Internal Audit and Management Review Committee. Members to the Committee serve until they are replaced. The Board of Internal Audit and Management Review Committee arranges for the half yearly internal audit to be conducted. The date for the audit is established by mutual agreement between the Board of Internal Audit and Management Review Committee and the General Manager Production and Asst. Manager Production (AMP). The audit is conducted by any member of the board or Internal auditor qualified to participate on the Certification Board so long as the auditor is not a member of the QA Management Committee, is qualified and knowledgeable in certification, auditing. The audit must be conducted at least every 06 months. During the audit, personnel responsible for the area audited are immediately notified of the outcome of the audit of their area. During an audit, it is possible that a difference of opinion can arise as to the severity of an observation. It is important not to spend too much time debating the merits of the observation. If it does not appear that the difference of opinion can be resolved, then the auditee should be informed that the audit report is subject to review by the Board of Internal Audit and Management Review Committee and the QA Management The draft report is issued to the Board of Internal Audit and Management Review Committee within 14 calendar days. The Committee members review and comment on the report and a final report is issued. The final internal audit report is submitted to the QA Management Committee. The QA Management committee drafts a response to the audit report that is finalized after review: Findings, nonconformities, trends, and other opportunities for improvement are identified; investigated to determine the causes; and corrective/preventive actions are developed. These actions are implemented as soon as possible and recorded. The response to the internal audit report is submitted to the Board of Internal Audit and Management Review Committee for their concurrence. Upon agreement on the response to the internal audit, the Board of Internal Audit and Management Review Committee prepares a complete Certification Program Management Review Report that includes, as appropriate,: Results of internal and external audits Feedback from clients and interested parties related to the fulfillment of the Certification Process Feedback concerning impartiality Follow-up actions from previous Certification Program Management Review Reports The status of corrective or preventive actions The fulfillment of objectives Changes that could effect the management system Appeals and complaints The Board of Internal Audit and Management Review Committee submit their Certification Program Management Review Report to the QA Management Committee. The Certification Program Management Review Report with the response to the internal audit is discussed at the next meeting of the full Board. The expected outputs of the review includes decisions and actions related to: Improvement of the effectiveness of the management system and its processes. Resource needs. Decisions and actions of the Board are documented in the Board Minutes and all open Corrective/Preventive Actions are reviewed and their status documented at all subsequent quarterly Board Meetings. Effectiveness of completed actions is reviewed at the next Program Management Review.6.0 Abbreviations : GMP: Good Manufacturing Practice QA : Quality Assurance
Self Audit Checklist for Production Department Sr. No.Check pointsObservationRecommendationAction taken by
1. Is the control copy of production department SOPs available?
2. Are the personnel having knowledge of current GMP requirements?
3. Are the lots of raw material properly stored?
4. Are the lots of raw material having proper labels of status?
5. Is the housekeeping maintained?
6. Is the weighting balance having proper tag of calibration status?
7. Is the balance calibration record available?
8. Are the calibrated standard weights available?
9. Is the calibration certificate available?
10. Is the standard weights are properly stored?
11. Is the reactor area cleaned?
12. Is the status label of reactor available?
13. Is the BMR requisition slip record available?
14. Check the calibration status of temperature gauges.
15. Check the calibration status of pressure gauges.
16. Check the status of centrifuge.
17. Check the cleaning of centrifuge and centrifuging area.
18. Check the condition of centrifuge bags.
19. Check the status of dryer.
20. Check the cleaning of dryer and drying area.
21. Check the calibration status of temp, Gauge of dryer.
22. Check the trays and trolley condition.
23. Check the status of sifter.
24. Check the cleaning of sifting area.
25. Check the status of multi mill.
26. Check the cleaning of milling area.
27. Check the finished product packing area.
28. Check the availability and stock of packing materials.
29. Check the temperature and humidity record.
30. Check the cleaning of sampling devices.
31. Are all the sampling devices properly stored?
32. Check the general cleaning and housekeeping of plant.
33. Check the test request slip record.
34. Check the personnel hygiene.
35. Check the safety equipments.
36. Check the other records.
37. Is ECR available?
38. Check the ECR.
39. Check the condition of fluid bed dryer.
40. Check the condition of reactors.
41. Are there work instruction labeled on all equipments.
42. Are records maintained for Solvent Receipt, Usage & Recovery In Plant?
43. Check the records of Solvent Receipt, Usage & Recovery In Plant.
44. Is there any training record for new employee?
45. Check the training record and training schedule.
46. Is the pipeline properly marked with directional arrows?
47. Is logbook of all Equipment properly maintained?
Vendor Audit for Validation
1.GENERAL: Observation
1.1Building Maintenance
______________
1.2Reception
______________
1.3Administrative Block/Office
_______________
1.4Utility Block
_______________
1.5Maintenance
_______________
1.6Surroundings
_______________
2.PERSONNEL:
2.1:Organization Structure
2.2:Qualification & Experience of technical staff
2.3:Provision for pre-employment:
Medical Check Up
For Staff :
For Operators :
2.4:Periodic Medical Check Up
For Staff :
For Operators :
2.5:Factory Clothes
For Staff :
For Operators :
Washing Schedule :
2.6:Personnel Hygiene __________ _____
Shower / Wash Basins :
WC / Toilet : ______________
Lockers :
_______________
Canteen :
_______________
2.7:Job descriptions andResponsibilities defined: ______________
2.8: Training carried out in critical areas._______________
2.9:Entry procedure in production area with protective garment in critical area.
_____________
2.10:Drinking , smoking , eating in production area are restricted _______________
2.11:System to avoid personnel contact with product._______________
2.12:Personnel suffering from infectious disease are restricted to work in production area. _______________
3.PLANT & BUILDING :
3.1:Well equipped and sufficient area for Storages
a):Raw Material
____________
b):Packing Material
____________
c):Intermediate
____________
d):Finished Goods
____________
e):Cleaning / Schedule
____________
f):Cleaning of used equipment and accessories____________
g) :Separate area for storage of incoming material
Quarantine area
Approved materials Storage
Rejected material Storage
Sampling area
Dispensing area
3.2Adequate cleaning , washing and toilet area
3.3Separate canteen area
3.4
Utilities like compressed air, steam, nitrogen gas area qualified and lines are identified with arrow mark for flow direction.
3.5HVAC are providing for critical operation.
3.6 Drain is properly sanitized for critical area.
3.7
Water purification system
3.8Water distribution system and quality of water used
3.9Men and materials movement system
3.10Area is product dedicated or group of products are manufactured then se the list of the product.
3.11Cross contamination possibilities
3.12Area cleaning procedure
3.13Procedure of handling of rejected material.
3.14Lighting level
3.15Handling of sewage and waste
3.16Sanitization of process equipments
3.17Pest control system
3.18:EQUIPMENT
a)Design MOC of contact parts
b)Qualification of equipment
c)Cleaning operation and preventive maintenance procedures
d)Cleaning frequency
e)Measuring device calibration procedure
f)Cleaning validation approach
g)Computerized system are qualified as per CCF part 11
h)Access to the computerized system is limited
k)Identification
l)Cleaning requirement for same product for Product Change Over
m)Housekeeping & Sanitation
n)Special Procedure / Precaution
4.MANUFACTURING CONTROL:
4.1:Identification level for material under processing
4.2:Written Manufacturing Procedure
4.3:Deviation Control Procedure
4.4:Means of Communication
4.5:Status label for rejected / released material
4.6:Used container control
5. TSE QUESTIONNAIRE:
5.1: Have you obtained the COS Certificate from EDQM for the Material you are supplying to us? If yes please attach the copy.
5.2: Is any of the starting material used in the manufacturing from Animal Origin. If yes, Please ensure to obtain the TSE free Certificate from your supplier.
5.3: Is the Production Line dedicated?
5.4: If NO Please Specify:-
a) Are the equipments shared with any other product, which uses the animal original starting material?
b) Do you have sufficient Cleaning Procedure?
b) Is cleaning procedure validated?
5.5: Is your batch COA contains the TSE / BSE free Declaration. If no submit an undertaking to send the batch wise TSE / BSE free Declaration for all supplies to us?
6.RECORD KEEPING :
6.1: Material issue control ________________
6.2: Equipment Log ________________
6.3: Process Record ________________
6.4: In-Process Results ________________
7. RAW MATERIAL CONTROL:
7.1:Raw Material Receipt Control
__________________
7.2:Approved Material Segregation
__________________
7.3:Rejected Material Control
__________________
8. QUALITY CONROL:
8.1: Raw Material Specification / Test Procedure & its control_______
8.2: Calibration Record ______
8.3: Finished Product Analysis & Release control _______
8.4: Testing facilities _______9. INFORMATION RELATED TO OTHER PRODUCT MANUFACTURED:
9.1: List of product manufactured (Attach Sheet)
9.2: Product change over control (Cleaning Validation) _______
10. FILING SYSTEM:
10.1 Retrievable ______________
11. NON CONFORMANCES IF ANY:
CRITICAL MAJOR OTHER
12. CORRECTIVE ACTIONS:
13. PREVENTIVE ACTIONS:
14. CLOSURE OF AUDIT:
CONCLUSION
SIGN
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Monday, December 6, 2010Self Audit Checklist for Maintenance Department Sr. No.Check pointsObservationRecommendationAction taken by
01Is the control copy of Maintenance department SOPs available?
02Is the personnel having knowledge of current GMP requirements?
03Is the preventive maintenance schedule available?
04Check the preventive maintenance records.
05Are equipments labeled with last maintenance date and next due maintenance date?
06Are the equipment qualifications available?
07Check the equipment qualification record.
08Is the temperature gauges calibration record available.
09Check the temperature gauges calibration record.
10Are the pressure / vacuum gauge calibration record available?
11Check the calibration record.
12Check the break down maintenance record.
13Check the DM water generation record.
14Check the AHU maintenance record.
15Check the AHUs filter cleaning record.
16Check the AHUs differential pressure record.
17Is there any training schedule for new entrant in maintenance department?
18Are new entrant trained after join maintenance department?
19Are there any documents for postponement of the schedule maintenance?
20Is the department follow the postponement of the schedule maintenance and send it to review by QA department?
21Is there check list for each equipment for preventive maintenance?
22Check the equipment check list.
23Are all electrical motor labeled and well maintained?
24Check the status of the electrical motor.
25Check the maintenance status of DG Set.
26Is the maintenance store area clean?
27Check the housekeeping of maintenance store area.
28Are all storage tanks properly labeled?
You might also like: Out of specification (OOS) result in Microbiological Analysis 1.0 OBJECTIVE: To lay down a procedure for handling of out of specification (OOS) result in Microbiological analysis and monitoring.2.0 RESPONSIBILITYQuality Control Executive/ Microbiologist3.0 ACCOUNTABILITY Quality Control Manager4.0 PROCEDURE In all the reports the identified reason shall be written on a continuation sheet to the annexure provided. A copy of the above investigation report shall be maintained with the batch manufacturing records concerned to increase awareness and for any future reference4.1 Sterility test4.1.1 If evidence of microbial growth is found, the product to be examined does not comply with thetest for sterility, unless it can be clearly demonstrated that the test was invalid for causes unrelated to the product to be examined .The test may be considered invalid only when one or more of the following conditions are fulfilled:4.1.1.1The data of the microbiological monitoring of the sterility testing facility shows fault;4.1.1.2 A review of the testing procedure used during the test in question reveals a fault;4.1.1.3 Microbial growth is found in the negative controls;4.1.1.4 After determination of the identity of the microorganisms isolated from the test, the growth of this species or these species may be ascribed unequivocally to faults with respect to the material and / or the technique used in conducting the sterility test procedure.4.1.2 If the test is declared to be invalid it is repeated with the same number of units as in the original test.4.1.3 If no evidence of microbial growth is found in the repeat test the product examined complies with the test for sterility. If microbial growth is found in the repeat test the product examined does not comply with the test for sterility.4.2 ENVIRONMENTAL MONITORING 4.2.1 If the microbial counts are found to be more than or equal to the alert limit then open a deviation report (annexure I) through Q.C. Head to the concerned Production head. Production personnel shall check the working discipline, supply of air, safety measures etc.4.2.2 If the count exceeds or reaches the action limit then the urgent notification to the Production head and Engineering Head through Q.C. Head shall be followed by an investigation for the same. - Supply of air - Working discipline - Review of data from the same place and others from the incubated plates- If any of the plates does not indicate the same then no action is necessary.- If any of the plates indicates more count then perform additional cleaning, disinfection or fumigation and retraining to the operator shall be given.- All activities shall be recorded as per the annexure attached with this SOP.- More number of samplings (i.e. double the original) shall be preformed at the same location where the counts observed were beyond or equivalent to the action limit but an additional relevant parameter of monitoring shall also be performed which shall be incorporated with the same annexure.- All the batches manufactured during the said period shall be subjected to the microbial analysis for MLT / Sterility &BET in order to ensure that the batches manufactured are in accordance with the relevant finished product specifications. The investigation report shall be submitted to the Q.C. - Head 4.2.3 If the bio-burden is found out of specified limit in the core areas the identification of the organism shall be performed. 4.2.4 Stop the production immediately and check all the possible parameters, which can affect bio-burden of the area.4.2.5 Check the pressure differential of the area, which must be within the specified limit. 4.2.6 Check the air velocity of LAF /HEPA filters, which must be within the specified limit. 4.3 If the investigation / review of manufacturing activities (e.g. sterilization process, aseptic filtration, environmental conditions, personnel practices) indicates failure of manufacturing activities, then the batch shall be considered as failed to comply sterility.4.4 MICROBIOLOGICAL AND BET EXAMINATION OF WATER If only the alert is exceeded without finding an undesirable microorganism the release of the preparation for which this water has been used, has to be taken under hold till the result comes. In case of the counts touching the action limit then all the batches manufactured shall be re analyzed by taking 25 grams and making the allowance for the larger size specimen for the analysis.In the case of counts crossing or touching the alert limit or action limit in any type of water the same will be intimated to the production department and maintenance department. If the result cannot be attributed to the analytical error, sampling error, contamination in the container sampled then the microorganism detected must be identified / differentiated by taking sample from all other points.4.4.1 Adequate sanitization of the system shall be ensured to eliminate the source of contamination with a rigorous check for the same.4.4.2 All the investigations made shall be recorded in the annexure III provided with this SOP. 4.5 MICROBIOLOGICAL EXAMINATION OF RAW MATERIAL / FINISHED PRODUCT4.5.1 The first action is to intimate the Q.C. Head.4.5.2 Retest the same material/product but with a sample size of 25 grams by making allowance for the larger size specimen.4.5.3 Results for the same shall be intimated to the Q.A. Head for final decision.5.0 REASON FOR REVISIONHarmonization of format6.0 TRAINING:Trainer -- Head Quality Control Trainees-- Quality Control Chemists & Assistants Period-- One day 7.0 DISTRIBUTION:Certified Copy No. 1 : Head of Department Quality ControlOriginal Copy : Head QUALITY ASSURANCE.
ANNEXURE IFORMAT FORDEVIATION REPORT TO PRODUCTION DEPARTMENT(Deviation Report About the environmental monitoring)REF. SOP NO.: Revision No. : 00Page No.: 1 of 1
Effective Date:
Sampling point where deviation occurred: Date: Name of the Product Batch no.:
Deviation : Parameter: Requirement : Results : Signature :
Corrective action in Production Department: Cleaning, Disinfection, Change of disinfectant, Checking of LAF unit parameters Checking of HVAC system, Education to Operators, Repair/Maintenance Work (Cross whichever is not applicable and specify actions taken). Maintenance Repair / Comments : ..Name : Signature : Date:
Repeated Sampling :Parameter: Result:Comments by Q.C. Head for Approval of Production :
Signature :
ANNEXURE - IIFormat for Corrective Report After Sampling of Environmental Parameters in ProductionREF. SOP NO.: Revision No. : 00Page No.: 1 of 1
Effective Date:
Date : Deviation :Date of repeated deviation :Corrective Measures in Microbiological LabChecking of condition s of LAF unit during working , Checking of equipment Growth promotion test for the media used.Done By : Checked By : Results of Microbiological Impurity of Finished Product :Name : Date : Signature :Comments of Quality of Quality of Control - Head :Name : Date : Signature :Comments of Quality Assurance - Head :Name : Date : Signature :
ANNEXURE IIIINVESTIGATION REPORT FOR FAILURE IN TEST FOR BACTERIAL ENDOTOXIN & M.L.TREF. SOP NO.: Revision No. : 00Page No.: 1 of 1
Effective Date:
Sample Analyzed on Analysed By Checked By Preparation parameters for Sampling container Procedure of sampling GP test of mediaAny testing error BETMicro tips Test tubes Pipette LAL reagent Batch No. Mfg. Expiry Reconstituted on
.LAL Reagent water Batch No. Expiry Blank Parameters of depyrogenation/sterilization apparatus: Validation Status Calibration Status Results of other samples with same conditions tested on the same day. Details of Raw material used in finished product Result Test repeated Date Result Microbiologist ACTION TAKEN :Production Head Engineering Head Quality Control HeadCONCLUSION(Results of MLT for Other Samples to be enclosed)Microbiologist QC ManagerDate: Date:Remarks from Q.C. HeadName: Sign Date :You might also like: Disposing of microbiological culture media Out of Specification Procedure Reprocessing of Out of Specification Batch OUT OF SPECIFICATION INVESTIGATION FORM Contract Laboratory Approval Questionnaire
S. No.Questions
1.0GENERAL INFORMATION
1.1Name and Address of Laboratory:
1.2Contact Person:Name:
Phone No.: Mobile No.: E-mail ID:
2.0FACILITIES:
Please specify what type of analysis you are performing?
3.0PERSONNEL:
3.1Number of Staff:No.
Director(s)/ responsible person of the organization:
Head/ Responsible person for Analysis:
Q A:
Q C:
R & D Lab:
Microbiology:
Others:
3.2No. of Approved persons:
S. No.QuestionsYesNoComments
3.3Do you have a written training program for analyst?
3.4Does your training program include the following:
GLP
GMP
Job training
Safety and Environmental issues
ISO principals
3.5Is efficiency of training regularly checked?
By examination
By any other relevant process
3.6Are there written job descriptions for all employees?
4.0INSTRUMENTS AND CALIBRATION:
4.1Is there an approved preventive maintenance program for all equipment used in laboratory?(Attach a list of Instruments)
4.2Is SOP of all instruments present?
4.3Is SOP of calibration of all instruments present?
4.4Are all instruments properly calibrated and labeled?
4.5Is there a calibration calendar maintained?
5.0QUALITY MANAGEMENT:
5.1What is your QA System based on?
GMP
cGMP
USFDA
ISO 9001:2000
5.2Are you regularly inspected?
By clients
By National authority
By Foreign authority
By FDA
S. No.QuestionsYesNoComments
5.3Does your Laboratory have GMP/ USFDA /cGMP/ ISO approval? If Yes specify
Name of authority Date of Certificate1. 2. 3. (Attach copy of certificate)
6.0QUALITY ASSURANCE
6.1Is there system for rejection of sample?
6.2Do you have specification approved by QA for working/reference standards of the product?
For Physical, Chemical requirements
For Microbiological requirements
6.3Is there procedure for sample handling and its inspection regarding:
Name of customer
Sample quantity
Batch No.
Date
Product related to Pharmacopoeia
6.4Do you use statistical method for evaluation?
Total sample received
No. of sample passed
No. of sample failed
6.5Do you have all documented procedures for each and every step?
6.6Are there validated:
Analytical procedure?
Cleaning procedure?
7.0ENVIROMENT MANAGEMENT SYSTEM:
7.1Do you have any environmental policy?
S. No.QuestionsYesNoComments
7.2Do you have ISO 140001 certificate?(Attach copy)
7.3Do you check the environmental conditions of laboratory regarding:
Temperature
Relative Humidity
8.0WATER:
8.1Which type of water used for analysis?
8.2How will you check the quality of water and it is free of contamination?
Questionnaire filled by:NameSignature and stamp of companyDesignation Date:You might also like: Vendor Approval Questionnaire Sending sample to contract lab CLEANING OF QUALITY CONTROL LABORATORY APPROVAL AND REJECTION OF PACKAGING MATERIALS LinkWithin Posted by Quality Assurance and GMP and ICH at 11:58 AM 0 comments Email This BlogThis! Share to Twitter Share to Facebook Share to Google Buzz Links to this post Reactions:
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First Aid 1.0 Purpose:To provide a documented guideline for the first aid treatment n case of any accident.2.0 Objective: To provide a first aid treatment.3.0 Scope: Employees / Visitors / workmen. 4.0 Responsibility : Follow up : Officer Personnel & Administration Over all responsibility : General Manager (Adm).5.0 Procedure : Training First aid training shall be given to selected employees of each department. Detail training of the first aid shall be given to some employees of the company. The list is as follows and shall be available in each department for easy reach out during emergency. List of trained employees
Serial No. Department Name of Trained employees
The first aid box shall be numbered and located at identified and marked positions as following
Locations of first aid box
Serial No. First aid box numberLocation of First aid Box
Each first aid box shall contain following -
Contents of first aid box
Serial No. First Aid box Contents Quantity
Every Monday from Personnel department personnel or General Manager (Adm) shall Review the contents of first aid box and shall replenish the required item. The Record of review shall be kept.
Review of first aid box
Date/dayContents checkedOK/not OKReplenishment detailsReason for replenishmentReviewedbyDiscardedItemssubmitted to QA.
Accident Prevention Guidelines 1.0 Purpose : To provide a documented procedure for preventing accident & Recording accident.2.0 Objective: To maintain safety aspects3.0 Scope : Preventing accident & Recording accident4.0 Responsibility : Follow up : Concern department head Over all responsibility: Personnel & Administration Manager. 5.0 Procedure: Accident Prevention Workman shall engage themselves in the duties which have been assigned to them. The execution of their duties must be in the safe manner laid down in S.O.P. for the operation, of the machine or duty concerned. Removal of guards or safety devices, cleaning of machines which they are Running, etc., are expressly forbidden. Workmen working beyond the height of 10 feet shall wear the safety belt. If any employee / work man working beyond the height of 10 feet on ladder shall work with one additional work man / employee to hold ladder. Safety instructions given or posted on Notice Boards are to be followed. Workman shall not keep sharp edge tools into their pocket. Any employee / workman working with electricity shall wear safety shoes & Sock proof gloves. Any workman working with hazardous chemicals / acid shall wear the safety Wears like goggles, gloves etc. Speed of vehicle inside the factory premises shall not exceed 20 km / hr. When welding work is to be carried out in closed area, extra fire extinguisher Shall be provided. After working with oil, floor shall be cleaned thoroughly to wipe out the oil. Solvents shall be stored in tight closed container. Used drums of solvent / chemicals shall be discarded by skilled workman. Sufficient emergency light shall be provided. Entry into transformer yard / explosive storage yard shall be restricted to selected Personnel. Machine which is under maintenance shall be labeled as Under Maintenance. Workman shall enter into water tank, drainage, septic tank only after permission Of Personal & Administration department. Workman shall carry out repairing work of high pressure line / high temperature Line / or any explosive line only after permission of Engineering In charge. Wear earplugs near high noise area. Recording of Accident Accident shall be recorded into Accident Register. The accidents are categorized as critical major and minor depending on the Seriousness of the incident. Action taken upon Accidents: The First aid, if required, after the accident shall be provided at the earlier marked Locations and trained persons are available. The telephone no. of fire station, doctor, ambulance shall be displayed in all the Departments to call upon in an emergency. The affected employee shall be immediately rushed to the hospital, if needed and is provided the required medical help.Top of Form
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Tuesday, December 14, 2010Guidelines for production activities as per safety & cGMP requirement 1.0 Purpose : To provide guideline to ensure that different production activities are carried out in compliance with safety & cGMP requirement, at pre-determined frequency.2.0 Objective : To provide a documented guideline to ensure that different production activities are carried out in compliance with safety & cGMP requirement, at pre-determined frequency.3.0 Scope : Scope of this SOP covers all the production disciplines.4.0 Responsibility : Primary : Officer Production Secondary : Executive Production5.0 Procedure : ORGANISATION & FUNCTION: The department must have a team that would perform all the function meeting cGMP requirements. It must also address to documentation, audits and training aspects pertaining to production jobs. The production department organization must be structured to ensure that production functions are carried out safely, in accordance with cGMP requirements, efficiently and promptly to support other service areas. It must be resourced with adequate numbers of appropriately qualified and trained staff. PREVENTION OF CONTAMINATION AND CROSS CONTAMINATION: Before starting any process in equipment make sure equipment should be cleaned and line clearance has been given by QA. The production area should be clean and free from dust and dirt so the intermediate and final product could not be contaminated. The cleaning of production area should be looked after by PA department. TRAINING: All the staff shall be covered for cGMP, Safety and Job-related training as per the training procedure. STANDARD OPERATING PROCEDURES: SOP must be prepared for all activities that are quality critical or safety critical or relate to key business areas. These SOPs must be prepared, reviewed & authorized and controlled in accordance with Site SOP. The SOPs must include specific maintenance instructions, lubrication details, Spares requirements, frequency of maintenance, responsibilities for carrying out the job & documentation, etc. as appropriate. The department activities must be reviewed to identify operations which need preparation of SOP and the current SOPs must be updated / reviewed as scheduled. AUDITS: Department audits must be carried out to monitor the production aspects of departmental activities in regard to its impact on SHE, Energy Conservation and Quality matters. VALIDATION: According to cGMP requirement process validation should be done. CHANGE CONTROL: All changes must be fully documented, assessed and authorized prior to the work being carried out. In line with good documentation practice, change in process must be controlled as per the good manufacturing practices. If any Change occurs it should be reported to QA department with reason. DOCUMENTATION: A separate list must be made for numbering and authorization documents. The documents will include following: Batch Manufacturing Record : Documentation pertaining BMR is to give information about progress in production of intermediate as well as final finished product include every information regarding to the product like analytical report, condition of reaction given for reactor etc. Equipment Cleaning Record: Before conducting next step in process cleaning of equipment should be required. To follow cGMP ECR should be filled by production department before starting every process. By checking ECR, QA department give line clearance to production department. Validation Documents: Documentation pertaining to validation would include protocol and reports for DQ, IQ and OQ activities and would be in line with the guidelines given. Protocols and reports must also include suppliers documentation (e.g. pressure test, calibration certificate, etc.) besides the reports generated at site.You might also like: ICH Guidelines for Pharmaceuticals GUIDELINES FOR EMERGENCY MANAGEMENT PLAN SAFETY MANUAL AS PER ICH GUIDELINES Instructions for Engineering department as per safety and cGMP requirements LinkWithin Posted by Quality Assurance and GMP and ICH at 2:29 PM 0 comments Email This BlogThis! Share to Twitter Share to Facebook Share to Google Buzz Links to this post Reactions:
Monday, November 29, 2010GUIDELINES FOR EMERGENCY MANAGEMENT PLAN ON-SITE EMERGENCY MANAGEMENTEmergency Leader / Main Controller (Senior Plant Manager).
Co-ordinate all activities from Emergency Control Center.
Duties:
Assess extent and nature of emergency.
Sequential stoppage of operation as per requirement.
In case of fire, necessary arrangement and provision of fire squad and systems to the emergency spot and its neighbouring sections.
Organise necessary ambulance and medical treatment for affected persons if required.
Arrangement of necessary hospitalization of victims.
Evacuation of site (partially or full) if required.
Preserve evidence.
Organise investigation.
Before allowing re-entry to the site check if the conditions are safe (Toxicity, fire hazard, structural stability etc.).
Re-starting of plant operations only after ensuring steps for prevention of re-occurrence.
Arranging for evacuation of neighbouring population if need be
Deal with media.
ADVISORY TEAMResponsibility of Advisory Team.
On hearing the emergency alarm will proceed emergency control center.
Remain with Emergency Leader at the emergency control center and advice him as needed.
In case Emergency Leader has to leave his post for some reasons any of the member of the Advisory Team will take over as the Emergency Leader.
If needed Factory Manager can deputy Emergency Leader to the site to be of help to the incident controller.
Deal with media.ACTION TEAM A Shift in-charge of affected plant.
Dy Manager / Asst. Manager of affected plant.
P.E. of affected plant.
Inform emergency control center / security about location and nature of emergency.
Inform his department head.
Minimise the consequence by
Eliminating source of ignition.
Shutting down the operation as per requirement and other areas as guided by the incident controller.
Arranging to activate fire hydrant system.
Ensuring the appropriate use of fire fighting material by fire fighting squad.
Stopping loading / charging operations.
Evacuating the plant if required in consultation with incident controller.Department HeadTake over the responsibilities of the shift in-charge upon arrival and proceed as listed above.
Security and Fire Fighting squad
Proceed the scene of emergency
Consult the shift in-charge and decide the line of action.
Ensure the stock of fire fighting material.
ACTION TEAM A
DUTIES OF SENIOR CHEMISTS:
1. As shift in charge will be involved in fire fighting operations senior chemist will ensure that Operations of affected area will be stopped and reactions will be stopped in safer mode with consulting shift-in-charge.
Evacuation of affected area.
Shifting of raw material intermediates from affected area.
Duties of chemists and junior chemists.
2. Chemists and junior chemists will form fire fighting team with guidance of incident controller start fire fighting with fire extinguishers and then with fire hydrant system if required.
ACTION TEAM B
Shift-in-charge of neighbouring plant / departments.
Dy. Managers, Ams, neighbouring plant / departments.
Manager Maintenance
Manager Electricals.
On hearing AlarmWhen instructed by the Emergency Leader
Ensure that Fire hydrant pumps are in operation.
Inform people about the emergency.
Prepare for the evacuation with short notice.
Arrange head count, repeat this at Assembly point.
AMs, Dy. Ams of other Department.
Proceed to own areas.
Take over responsibilities from shift-in-charges and ready to shut down plant if needed.
Manager Maintenance
Provide Engineering assistance to Emergency Leader.
By ready with rescue equipments to extricate trapped personnel.
Manager Electricals.
Ensure that adequate power supply is made available for sensitive plant operation and emergency lighting.
Make available an electrician near incident controller.
ACTION TEAM C
Security Officer / Safety Officer
On hearing Alarm
Security Officer
Proceed towards emergency.
Control traffic.
Arrange guard at gate to inform essential personnel.
Prevent unauthorized entry at gate.
Get additional help if needed.
Communicate with city Fire Brigade.
Arrange Fire Fighting squad to fight fire.
Safety Officer
Proceed to scene of Emergency
Ensure adequate supply of safety appliances.
Inform with consultation with advisory team to Factory Inspector and other Authorities.
Offer any help expected, advice with First Aid render First Aid to injured person.
Keep in touch with doctors and medical team.
Ensure availability of vehicle for moving injured to hospital.
ACTION TEAM D
Doctors.
First Aiders
Stores-incharge
For Doctors / Nurse
Keep Ambulance ready to proceed to scene of Emergency at short notice.
Priorities causalities for treatment call First Aiders.
Consider sending causalities for specialist treatment.
Arrange hospitalization, additional ambulances.
For First Aiders
Proceed to the site and hospital as per decided by Emergency Leader to render assistance.
Stores-in-charge.
Arrange additional supplies of Fire Fighting or Safety equipments as required.
ACTION TEAM E
All staff members not listed in emergency action team.
Contact workmen and supervisors.
On hearing Alarm
Get back to work places (if safe) and await instructions from supervisors.
Avoid panic
Do not go to the scene of Emergency unless specifically instructed by Emergency Leader.
Contract persons should stop work and assemble at security gate.
WORKS TO BE DONE FOR MOCKDRILL
1. Location of emergency control center2. Location of assembly polls.3. Emergency alarm system.4. Formation of observers team.5. Formation of fire fighting team from each shift.6. First aid training (specially to QC chemists as availability is round the clock).7. Facilities in First Aid / Ambulance room.8. Prior training of fire fighting to all teams.9. Training programs for all teams as per their functions.You might also like: ICH Guidelines for Pharmaceuticals Guidelines for production activities as per safety & cGMP requirement Guidelines for Engineering & Maintenance Internal Audit Plan as per GMP LinkWithin Posted by Quality Assurance and GMP and ICH at 4:09 PM 0 comments Email This BlogThis! Share to Twitter Share to Facebook Share to Google Buzz Links to this post Reactions:
Saturday, November 27, 2010ICH Guidelines for Pharmaceuticals
What is the purpose of ICH ?
The objective of ICH is to increase international harmonisation of technical requirements to ensure that, safe, effective and high quality medicines are developed and registered in the most efficient and cost effective manner.
Goal of ICH
The goal of ICH is to promote international harmonisation by bringing together representatives fromthe three ICH regions (Europe, Japan & USA) to discuss and establish common guidelines
Stability
Q1A(R2) Stability Testing of New Drug Substances and Products
Q1B Stability Testing : Photostability Testing of New Drug Substances and Products
Q1C Stability Testing for New Dosage Forms
Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
Q1E Evaluation of Stability Data
Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV
Analytical Validation
Q2(R1) Validation of Analytical Procedures: Text and Methodology
Q2A Validation of Analytical Procedures: Methodology (in Q2(R1)
Impurities
Q3A(R2) Impurities in New Drug Substances
Q3B(R2) Impurities in New Drug Products
Q3C(R4) Impurities: Guideline for Residual Solvents
Pharmacopoeias
Q4 Pharmacopoeias
Q4A Pharmacopoeial Harmonisation
Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
Q4B Annex 1Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Residue on Ignition/Sulphated Ash General Chapter
Q4B Annex 2 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Extractable Volume of Parenteral Preparations General Chapter
Q4B Annex 3 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Particulate Contamination: Sub-Visible Particles General Chapter
Q4B Annex 4A Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter
Q4B Annex 4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter
Q4B Annex 4CEvaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter
Q4B Annex 5 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Disintegration Test General Chapter
Q4B Annex 6 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Uniformity of Dosage Units General Chapter
Q4B Annex 7 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Dissolution Test General Chapter
Q4B Annex 8 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Sterility General Chapter
Quality of Biotechnological Products
Q5A(R1) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
Q5B Quality of Biotechnological Products : Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
Q5C Quality of Biotechnological Products : Stability Testing of Biotechnological/Biological Products
Q5D Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products
Q5E Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process
Specifications
Q6A Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances (including Decision Trees)
Q6B Specifications : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
Good Manufacturing Practice
Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Pharmaceutical Development
Q8(R1) Pharmaceutical Development
Quality Risk Management
Q9 Quality Risk Management
Pharmaceutical Quality System
Q10 Pharmaceutical Quality System
Q8/9/10 Q&As Questions & Answers document
You might also like: GUIDELINES FOR EMERGENCY MANAGEMENT PLAN Guidelines for production activities as per safety & cGMP requirement SAFETY MANUAL AS PER ICH GUIDELINES Quality Manual as per ICH Guidelines LinkWithin Posted by Quality Assurance and GMP and ICH at 3:30 PM 0 comments Email This BlogThis! Share to Twitter Share to Facebook Share to Google Buzz Links to this post Reactions:
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Blog Archive 2011 (2) 01/09 - 01/16 (2) Available Guidance and Best Practices for Conducti... Procedure Of Corrective And Preventive Action 2010 (224) 12/26 - 01/02 (19) Procedure for conducting Stability Studies Out of Calibration of instruments Analytical report numbering Validation of QC Chemist Record maintained by Quality control department Labeling by Quality control department Functions of Quality control department Cleaning of HPLC columns Re-testing of raw materials and intermediates Acceptance of raw materials on supplier certificat... Sending sample to contract lab Sampling, testing and release of raw materials Calculation in QC department Opening and closing of QC department Cleaning of sampling tools Standardization and storage of Reference and Worki... Preparation, Standardization and Shelf-life of Vol... Sampling of Raw Material Internal Audit Plan as per GMP 12/19 - 12/26 (1) Quality Control of Capsules 12/12 - 12/19 (59) Calibration of Disintegration test apparatus Calibration of Friability test apparatus Calibration of serological water bath Bar Coding System for packaging materials Code numbering system of packaging material Cleaning & Sanitisation of Sampling room Operating Leak test Apparatus Sampling and Testing of packing materials Operation of colony counter Operation of compound microscope Out of specification (OOS) result in Microbiologic... Media Fill operation in the sterile dry powder fil... Disposing of microbiological culture media Preparation of Microbial Plates Operation and Cleaning of Laminar bench Maintaining of Bacterial Cultures Limulas Amoebocyte lysate test (LAL) Monitoring Personnel of sterile area in Aseptic ar... Operation and Calibration of Heating-Blocks Environmental monitoring of the microbiology labor... Fumigation and de-fumigation of Aseptic area Swab sampling and testing for clean rooms Monitoring of Aseptic area by Passive air sampling... Air sampling in Sterile area Cleaning and disinfections of Aseptic area Validating Corporate Computer Systems: Good IT Pra... Guidelines for production activities as per safety... Requisition and issuance of Raw materials Solvent Recovery Environmental Monitoring Line Clearance prior to Batch Operation, and cleaning of Sparkler Filter. Operation, cleaning of Rotary Dryer Operation and cleaning of Milled Steel Reactor Operation, cleaning of Tray Dryer Operation, cleaning of Sifter Operation, cleaning of Multimill Operation, cleaning of Fluidized Bed Dryer(FBD) Operation and cleaning of Nutche filter Operation and cleaning 48 Stainless Steel Centri... Operation and cleaning of Glass Lined Reactor. Operation for Gas Chromatograph with Head Space-Sh... Calibration for Gas Chromatograph with Head Space-... High Performance Liquid Chromatography-HPLC (Shima... Fourier Transform Infrared Spectrophotometer (FTIR... Hot Over oven Karl Fischer Apparatus Magnetic Stirrer Analytical balance-Polar E-200 DX Melting Point Apparatus Muffle Furnace pH Meter Analytical balance-Libror Potentiometric Titrator Analytical balance- Mettler Toledo U V cabinet Humidity Chamber Digital Photoelectric Colorimeter Bulk Density Apparatus 12/05 - 12/12 (89) 11/28 - 12/05 (43) 11/21 - 11/28 (13)
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SAFETY MANUAL AS PER ICH GUIDELINES Chemical industries are more prone to safety hazards, in terms of fire, explosion etc., resulting in huge loses of resources and precious lives.
Hence, it is of utmost importance that each one, irrespective of his position in the organization should exhibit a high sense of responsibility to safeguard the safety of his area of operation, in his own as well as in the interest of the organization.
The hazards could be of various types, arising from chemical, mechanical, electrical or civil in nature.
1. Chemical Hazards:
Most of the accidents occurring in chemical industries are of this nature. The causes for the hazards can be attributed to:
i) Process deficiencies.ii) Faulty equipment designiii) Equipment failures.iv) Lack of training for the operating personnel.v) Improper storage and handling of incompatible chemicals.vi) Poor taste for GMP.vii) Human error, etc, etc.
i) Chemical processes:
The processes involving many of the chemicals with different chemical characteristics should be well established and validated in lab/ pilot plant scale before being implemented for commercial production. HAZOP study should be conducted for each stage of the process and possible hazards in the process should be eliminated.
ii) Equipment design:
Adequate attention should be paid while designing of an equipment for a process, taking into consideration of moc of the equipment, process parameters like temperature, pressure, safe operational capacity, safety gadgets like flame-arrester, vent line valve, control valves etc.
iii) Process equipments:
All process equipments which have bearing on the process control, such as temperature indicators, pressure / vacuum gauges, safety / control valves etc. should be of reliable quality and tested for performance before being installed. There should also be a system for periodic inspection and maintenance of these equipments.
iv) Training:
Training plays an important role in the skill development process. All the operational persons should be adequately trained for the job.
v) I. Storage and Handling of chemicals:
1. All chemicals based on their chemical properties and incompatible nature with other chemicals must be stored as stipulated in their MSDS.
2. Chemically incompatible materials should not be allowed to come into direct contact with each other under any circumstances.
3. Proper personnel safety equipments, such as apron, goggles, face shield, nose mask, safety shoes should be worn while handling corrosive and hazardous chemicals.
4. Adequate fire-fighting equipments such as fire-extinguishers, sand filled buckets, access to fire hydrant system should be provided near the storage place.
5. No loose electrical cables or cables with broken joints should be permitted in the storage premises. Proper earthing has to be done wherever flammable solvents are loaded or unloaded.
6. Right type of material handling equipments such as fork-lifter, drum trolley, cylinder trolley, etc should be available.
7. All electrical fittings, such as lighting, switches etc. in the storage area should be of flame proof category.
8. it must be ensured that MSDS (Material Safety Data Sheet) for all the hazardous chemicals being stored must be made available to the stores incharge and it is the responsibility of the stores incharge to make sure that the storage and handling is done in compliance to the procedures stipulated in the MSDS.
9. Persons operating in the material handling functions should be adequately trained to handle safety and fire-fighting equipments.
10. As a safety need, every storage room should be provided with an exit door, which is to be properly identified and kept un-locked.
11. Good house keeping is an important requirement in storage godowns. There must be clear passage area for free material movements.
v.2. In compatible chemicals:
1. There are chemicals, which remain harmless if stored in isolation, but upon allowing coming into direct contact, could pose severe fire, explosion hazards.
Some of this type of chemicals are
i) Con H2SO4 vs KMnO4 ii) Glycerol vs KMnO4iii) AcetoneMethanol vs CrO3Glycerine iv) Co. HNO3 vs alcohols, ketones, ethers etc. v) Sodium metal vs H2O vi) Sodium hydride vs H2O vii) Hydrogen peroxide vs flammable organic solvents
In all the above cases instant fire will take place, due to the high amount of heat produced as a result of the vigorous reaction between these compounds.
2. Certain type of chemicals is sensitive towards stress, shock and adverse thermal/pressure conditions. Subjected to any of such environmental conditions, they decompose at such a fast rate that it would lead to Explosions e.g.
1. Nitrates (ammonium nitrate)2. Persulphates (ammonium persulphate)3. Peroxides (hydrogen peroxide)4. Permanganates (potassium permanganate)5. Perchlorates (ammonium / sodium / potassium)6. Dichromates (ammonium)7. Hydroxylamines and their salts.8. Azides (sodium azide) etc, etc.
3. There are many chemicals which are highly reactive with water / moisture. Upon contact with water, they react violently resulting in Fire / Chemical splash. These are to be stored in leak proof water tight containers in a dry place, e.g.
1. Acetyl chloride 2. Aluminium chloride
3. Acetic anhydride 4. Thionyl chloride
5. Calcium hydride 6. Sodium metal
7. Sodium hydride 8. Con. Sulphuric acid etc, etc.
4. Few of the chemicals are very corrosive in nature and can cause severe blisters / deformity / loss of vision etc, if they come into contact with human body. All personal protective equipments such as hand gloves, apron, goggles, nose mask, safety shoes should be worn by those handling these chemicals e.g.
1. All mineral acids (HF, HCl, HNO3, H2SO4)2. Certain organic acids (formic and acetic acids)3. Alkalies (ammonium, sodium and potassium hydroxides)4. Chloro compounds (acetyl chloride, Thionyl chloride, mono and tri-chloro acetic acid, aluminium chloride etc.)
v.3. Storage of flammable solvents:
Based upon the degree of flammability (Flash points), flammable solvents are classified under the following 3 categories:
i) Class A-solvents having flash point 0 to 23oC.ii) Class B-solvents having flash point >23 to 65 oCiii) Class C-solvents having flash point >65 to 93 oC
v.3.1 Precautions to be observed in storage:
1. All solvents of category A and B should be stored only in metallic containers, well closed, in a cool place at the designated area.
2. No hot jobs such as welding, cutting or bracing is permitted inside the storage place or in the vicinity.
3. All electrical fittings and fixtures should be of flameproof in nature.
4. Adequate safety and fire-fighting equipments should be available for emergency.
5. Permission for entry should be through authorization only.
6. All relevant MSDS should be available with the incharge of stores.
7. No electric / battery operated equipment for material movement should be permitted in solvent storage areas.
8. Basic training for fire-fighting systems should be imparted to all the operating staff.
9. No fire generating materials, such as match box, cigarette lighter is permitted in the premises.
10. No solvent dozing operations is permitted in the storage area.
11. Flammable solvent storage warehouse should meet the statutory requirements of Indian Explosive Act.
vi. Static Electric Discharge and Fire Hazards:
One of the most hidden hazard, causing fire and explosion in chemical industry is associated with the unique property of several solvents and organic compounds to acquire electric charges termed as static electricity, which subsequently get discharged in the form of electric spark, causing the disaster.
Most of flammable solvents, particularly non-polar solvents, finely divided metallic and organic particulates, acquire static electric charges on their surface by virtue of constant motion, separation, abrasion or on prolonged stagnation.
vi) I. Causes for Static Electric Discharges:
1. By virtue of the chemical configuration of the material.
2. High velocity flow of a solvent through any non-metallic pipe.
3. Flow of a solvent down from a height in the form of a spray.
4. Storage in non-conductive containers like plastic / poly propylene / PVC or HDPE containers.
5. Inadequate earthing system.
6. Prolonged storage.
7. Spinning of a powdered material in a high speed centrifuge without being earthed properly. (The hazard will be more severe if the particulate contain even traces of flammable solvents).
8. Accumulation of too much dust particles in a confined area.
9. Low level of Rh in the vicinity.
10. Operations involving mixing, blending or spinning.
2. Preventive Measures
11. Allow flammable solvents to flow through metallic pipes only. These pipes should be earthed to the ground with proper conduits.
12. While charging a solvent into a reactor/container, ensure that the liquid is not dropped from the top to fall to the bottom. Always ensure that the liquid reaches the bottom of the vessel, through metal pipes.
13. Avoid storage in non-conductive containers, such as those with moc PVC/PP/HDPE. Always store only in metal containers.
14. Loading and unloading of bulk flammable solvents should be permitted only in authorized premises (refer Petroleum Act of India). Proper earthing connections should be provided to both the storage container and the receiver.
15. Before operating any centrifuge, ensure that it is being properly earthed to the ground. Also, before scooping out any material from the centrifuge, ensure that the metallic scoop is also earthed (plastic or nonconductive equipments are not advisable for scooping material from centrifuges).
16. To avoid dust explosion, which is likely in large powder handling units, provide adeauzte ventilation so as to prevent dust accumulation which is the cause for this kind of hfazards.
17. Wherever possible spray water in the surroundings of large solvent storages, as higher humidity helps to dissipate static charges (water particles are good electric conductors).
Caution:
Never ever let any live electric cable come in contact with earthing cables, as the consequences could be disastrous.
vii) Handling and Storage of Gas Cylinders
Handling of compressed and liquefied gases, contained in cylinders calls for special attention, as these are of potentially high hazards, in case of any leakage or bursting up of the container.
There are about 101 permanent, as well as liquefied gases, which are being conveyed in specially designed cylinders and these gases are contained under high pressures (18 kg/cm2 to 250 kg/cm2) and are identified with unique colour codes.
Some of the commonly used gases and the corresponding colour codes of the cylinders are:
vii.1. Precautions to be observed in storage and handling.
1. Always store filled gas cylinders in a cool and ventilated and sheltered area, away from heat and direct sunlight.
2. No hot jobs, such as welding, bracing, cutting or grinding, is permitted in the gas storage area.
3. Always keep the cylinder properly capped. The cylinder valve is the most delicate and vulnerable part of the cylinder. Never allow the Needle valve of the cylinder to get damaged, while loading/unloading and shifting operations.
4. Store the cylinders in vertical position, near a solid support, properly fastened with a metal chain to avoid their falling.
5. In case of any leakage of the cylinder, never attempt to repair the valve. Isolate the cylinder from the main stream and keep it in an open and cool area and seek help from the cylinder supplier.
6. The cylinder storage area should be located always, away from the main/process building and under no circumstances should any gas cylinder be used inside the processing areas. Gas cylinders should be kept away from corrosive acid fumes, which could corrode the cylinder body and damage the cylinder valve.
7. Never try to apply grease on the cylinder valve/nozzle, as certain highly reactive gases like hydrogen can ignite the organic mass, causing fire.
8. For shifting gas filled cylinders, always use cylinder trolleys and never let them roll on their body.
9. Never try to open any cylinder without having the appropriate type of regulators.
10. As a safe practice, always store the cylinders outside the building in the proper designated area, and draw the gases into the operational area through metal pipes with suitable safety valve.
11. Adequate training is to be imparted to those handling gaseous chemicals regarding safety equipments, first-aid measures and the antidotes to be applied in case of emergency.
12. It is always preferable to keep minimum possible inventory for better handling, especially for toxic and flammable gases.
13. Do not store incompatible gases together, as this could lead to explosion in case of simultaneous leakage from both the cylinders.
e.g. Hydrogen vs Chlorine Ammonia vs Chlorine
viii) Mechanical type of Hazards
Though hazards associated with mechanical type occur mostly in engineering industries, foundries, automobile sector, etc., they are also not uncommon in chemical industries.
Some of the safety precautions recommended are:
1. All the process equipments such as reaction kettles, pressure vessel etc. should be properly maintained and periodically pressure tested to ascertain their capability to withstand the optimum pressure for which they are designed.
2. Never ever subject the equipment to more pressure than the designed capacity. All equipments where pressure reactions are carried out, should be provided with safety pressure releasing valves.
3. The vent line of process reactors (except pressure reactors, designed for specific services) should be vented outside the process block, preferably through a scrubber, depending upon the nature of the effluent gases generated in the chemical processes.
4. All temperature indicators, pressure gauges, control valves, pressure releasing valves attached to the process equipments must be periodically tested and their proper functioning should be ensured (most of the accidents are attributed to equipment malfunctioning and breakdowns).
5. Ensure that all the moving parts of an equipment, such as the shaft of a drying oven, blades of a fan, coupling of a mechanical pump, the belt of a motor fan are provided with proper metal guards so that they do not come into contact with human body.
6. High speed hydro extractors should be periodically inspected through regular maintenance system to ensure that al moving portions such as the central shaft, mechanical pulleys, etc., do perform to the desired level.
7. All utility lines, conveying steam, chilled water, brine, vacuum, nitrogen etc, should bear clear identification tags and preferably they are to be identified with distinct colour code system.
8. As a safety measure it is highly advisable to purge nitrogen gas into the reaction vessels before start of the process, thereby reducing the oxygen concentration inside the reactor and thus reducing the fire risk.
ix) Electrical Hazards:
Safety precautions to be observed:
1. All electric fixtures such as cables, wires, switches, electronics fittings should be of standard quality and free from any manufacturing deficiency.
2. Overloading of any supply point by drawing more power than the recommended norm should be totally avoided:
3. It must be ensured that all the electric fittings, fixtures, lightings, induction motors etc, should be of flame proof quality.
4. All electric equipments and fittings should be safe guarded against moisture, chemical fumes etc, and periodically inspected by regular maintenance systems.
5. Electric panel boxes, main control switches etc. should be properly housed in a proper ventilated block, away from the plant and must be tagged for easy identification.
6. All equipments, receivers, storage tanks, barrels etc., should be adequately earthed to the ground through metal conduits and should be periodically inspected for their continuity of electricity.
7. Cables and electric wires used should be of single piece and should not have any joint.
8. Never let the electric and earthing cables come in touch with each other at any point.
9. Portable inspection lamps/lights should be strictly prohibited in the process blocks.
10. Keep the electrical panel box surroundings dry and provide rubber mats in front of the panel door to avoid any electric shock to the operating personnel.
11. Whenever any equipment is under maintenance / repairs, ensure that the power to the equipment is switched off from the main panel and proper tagging is done at the panel switch, as well as on to the equipment.
12. Only qualified and authorized personnel should be permitted to perform electrical jobs.
INDUSTRIAL FIRE AND PREVENTIVE METHODS
1. DEFINITION FOR FIRE:
Fire, combustion or burning of any substance needs basically 4 things to occur.
a) A fuel [this can be: any organic matter; such as a solvent, oil, wood, paper, etc.].
b) Oxygen [usually air].
c) A certain amount of energy in the form of heat.
d) Free radical reaction. The chemistry of combustion indicates that the union of Oxygen and the fuel is not direct, but through a series of steps wherein the actual reaction taken place between Oxygen and the free radicals liberated by the heated fuel at the point of ignition.
2. CLASSIFICATION OF FIRES:
Basically all the type of fires can be classified into the following major categories.
a) Class A Fires:
These are fires on ordinary combustible materials, such as paper wood, rags etc. which can be put off by the quenching and cooling effect of water. For extinguishments of such type of fires, use of water, form or dry chemical fire extinguishers would be effective.
b) Class B Fires:
These are fires occurring in flammable liquids such as oils, organic solvents, petro chemicals etc., where a blanketing or smothering effect is essential to put the fire out. Fire extinguishers like Foam, CO2, and Dry chemical are recommended for this type of fires, which provide a blanketing effect around the fire, thus, preventing air from coming into contact with the burning substance.
Water is effective for oil fires, only when it is used in the form of a spray or mist, but as such is not advisable to use in fires involving solvents and oils, which are immiscible with water.
c) Class C Fires :
These fires are associated with Electrical fittings, fixtures, such as electrical panel boxes, electric cables, electric ad electronic equipments etc. Non conductive extinguishing agent such as CO2 gas is the most ideal and recommended fire extinguisher for Electric Fires.
d) Class D Fires:
These are fires in metals, such as Li, Na, K, Zn, Mg etc. and mishandling of this type of fires can cause explosion and spread to other areas. Special attention and training is needed to handle metal fires.
Normal fire fighting agents used for extinguishing are dry sand, dry powder, graphite etc.
It is important to understand the meaning of some of the fire control terms and definitions of certain critical physical characteristics of solvents which will help to understand the degree of flammability of a particular Product.
1. Flash point (flash p):
This is the lowest temperature at which the liquid will give off enough flammable vapours at or near its surface, such that in an intimate mixture with air and a spark or flame, it ignites.
The flash point of a flammable liquid is usually determined by the standard method of test for flash point with the Tag Closed Cup Tester (TCC) or with the Tag Open Cup Tester (TOC). The results recorded with Tag Open Cup Tester (TOC) is always found to be 5-10oF higher (less flammable) than that being recorded with Closed Cup Tester.
The closed cup flash point value is usually several degree lower (more flammable) than the open cup, as the test in the former case is made on a saturated vapour-air mixture, whereas in the letter case, the vapour has free access to air and thus is slightly this reason open cup values more nearly simulate actual condition.
2. Fire point (fire p):
This is the lowest temperature at which a mixture of air and vapour continues to burn in an open container when ignited. It is usually above the flash point. Wherever the flash point data is not available, fire point figures can be considered as significant as flash point to understand the degree of flammability of the material.
3. Auto ignition temperature:
This is the temperature at which a material (solid, liquid or gas) will self-ignite and sustain combustion in the absence of a spark or flame. This value is influenced by factors such as the size, shape, the material of the hot surface, rate of heating etc. etc.
4. Vapour Density:
This value expresses the ratio of the density of the vapours to the density of air. The vapours of most of the flammable solvents are heavier tan air, with the result that they tend to travel at ground level making them more dangerous, as the risk will be more in case of a fire, since the vapours do not get diluted with air. Hence, in operational areas, where such higher V.D. solvents are used, the ventilating outlets should be at the lower level. Similarly, wherever, the liquids of low V.D. is handled, the ventilator should be at the higher level.
5. Melting point (mp):
This is the temperature at which the solid and liquid forms of a substance exist in equilibrium. This value also gives the indication at what minimum temperature a flammable solid substance can become flammable solvent.
6. Boiling point (bp):
This is the temperature at which the vapour pressure on the liquid surface becomes equivalent to the atmospheric pressure and at this temperature a continuous flow of vapour bubbles occur from throughout the liquid body and it is an indication as to how much volatile the liquid could be.
As the boiling point is proportionate to the pressure to which it is subjected to, it is apparent that lower the pressure (higher vacuum), lower would be the boiling point and lesser will be the vapour pressure and vis--vis.
This physical characteristic of liquids can be made use of, in preventing many hazards like Fire, Thermal decomposition of the product etc by subjecting the distillation process to take place under reduced pressure.
7. Chemical Formula:
In the event of lack of data regarding the flammable nature of a product, the chemical formulation of the product can give a clue regarding its flammable nature to a certain extent. For instance, if a product consists only of Carbon and Hydrogen (Hydro carbon), it can be assumed to be flammable and if it is in liquid form and having a low boiling point, it can be considered to be more flammable.
8. Flammable liquids:
Based on the degree of flammability, liquids of flammable nature are classified broadly into 3 categories as per the Petroleum Act of India.
v. Class-A solvents having the flash point 0 to 23oCvi. Class-B solvents having the flash point >23 to 65oCvii. Class-A solvents having the flash point >65 to 93oC
FIRE PROTECTION
The two major aspects of Fire Protection are 1. Prevention and 2. Loss minimization.
1. Prevention:
The most undisputed aspect of Fire protection is its prevention. Since, for a fire to occur, all the 3 basic requirements, Fuel, Oxygen and source of Heat are needed to combine, by avoiding any of the 3 basic requirements, Fire can be prevented. For instance let us take an example of an industry which uses large volumes of Acetone in an open atmosphere. Now, for a fire to happen, among the 3 requirements, two of them i.e. Fuel and Oxygen (from air) are already available in the vicinity. The third requirement for Fire is heat.
From the flash point data, Acetone has a Flash point of 0oF, which means that at all temperatures above 0oF Acetone would give out enough vapours which on combining with Oxygen of air, can form a flammable mixture in case if it comes into contact with a spark, flame or a hot surface or any other source of ignition. Thus, in an installation using Acetone, following avenues are available from Fire Protection point of view:
1. The working temperature (ambient) should be kept less than the Flash point, 0oF of Acetone, so that the vapour pressure of acetone at that temperature is lowered to considerable extent and consequently it does to give out enough vapours for the Fire to take place.
2. The supply of atmospheric oxygen must be cut off. This is possible in two ways.
i) By applying vacuum in the processes which taken away the air from the liquid surface.
ii) By providing a continuous stream of Nitrogen gas flow over the surface of the liquid (also termed Nitrogen blanketing).
3. Eliminating all source of ignition in the operational as well as in the surroundings and enforcing following steps:
i) smoking and carrying of materials of ignition, such as match box, unprotected electric lamps etc should be strictly prohibited.
ii) Hot operations, such as welding, gas cutting, bracing should not be carried out in and around the operational area.
iii) All the electrical fittings and fixtures and electric motors used in the process area should be Flame proof in nature.
4. The area must be ventilated so that even though acetone gives off enough vapour to form a flammable mixture with air, the vapour will be drawn out of the area by means of the fume exhaust as rapidly as it is formed, thus preventing the accumulation of vapour concentration.
Below is a brief account of the 3 essential supporters of fire and the means to reduce their influence for Fire Protection.
A) OXYGEN:
Although under certain specific conditions, chemicals can initiate fire even in the absence of oxygen for short duration (e.g. Fires associated with sulphur / phosphorous chlorine, hydrogen etc.), for sustained propagation of Fire, oxygen is very essential. Also the higher the concentration of oxygen in the atmosphere, more would be the intensity of fire. In industrial atmosphere it is difficult to manipulate the oxygen concentration in the working area, particularly since a concentration of oxygen, far below normal to keep fires from starting, would also be too low to support human life.
When it becomes necessary to work with such products, which by mere contact with air of atmosphere, can initiate a Fire, following steps are recommended for their safe handling.
i) Isolate such products, such as sodium azide, sodium hydride etc. which are highly reactive with atmospheric oxygen from the main stream of materials and store them in containers under vacuum, or follow the guidelines for storage as mentioned in their respective MSDS.
ii) Keep such products under a blanket of inert gas such as nitrogen, helium or argon.
B) HEAT:
In industrial fires the most easily overlooked fact is that all the major Fires that had occurred, had a modest beginning in the initial stages, which might have gone unnoticed and hence uncontrolled. Then, since fires are by definition exothermic, the very small fire started by a tiny heat source, supplies to its surroundings more heat than it absorbs, thus enabling it to ignite more fuel and oxygen mixture, and so on until very quickly there is more heat available than is needed to propagate a large Fire.
The heat for the initial Fire to start might have been provided by various sources of ignition such as high environmental (ambient) temperatures, hot surfaces, mechanical friction, spark from a switch, static electric discharge, an open flame or from a jot job, like welding, gas cutting etc.
It is worthwhile here to look into the various aspects of the ignition source and find ways to effectively curtail them.
a) Open flames:
It is of utmost importance that near the operating areas, wherein flammable solvents are being handled, strict vigilance be exercised to check heat sources like burners, lamps, matches, welding torches, lighting etc. If there are both type of operations, viz. operations involving flammable solvents and hot type of jobs, in the same premises, they should be isolated properly by thick wall of cement and bricks. Never should any flammable material such as wood / plywood / thermacoal be used for the construction of the partition.
b) Electrical sources:
Some of the common source of electric heating are from non certified lightings, cables, switches, starters, electric motors, digital electronic indicators, overloading of supply point, poor earthing systems etc. As a matter of safety, it is advisable to have all electrical switches and electric panel board properly housed in a separate block, away from the main plant / operating premises.
c) Over heating:
Processes which need high pressure steam and involve high temperature reactions, runaway reactions, special processes, etc. should be identified and these are to be segregated from the relatively safer processes. HAZOP study should be undertaken before the implementation of such processes and special attention has to be paid in training the persons operating such plants.
i. Hot surfaces:
The most common hot surfaces in a chemical industry are equipment like, drying oven, boiler, steam line, hot oil system etc. These equipments must be housed in a quarantined location preferably away from the operating area (boiler / thermo pack and electrically) heated drying oven in any case should be way from the process block). All the supply lines conveying steam, hot oil, hot water, hot air etc. should be properly insulated and maintained. It must be remembered that Flammable solvents, having the auto ignition temperature, lower than any of these hot surfaces, can get ignited themselves in case of their contact.
ii. Spontaneous ignition:
Many fires are caused by the heat of reaction produced when chemicals, incompatible in their chemical characteristics come into contact with each other, which are further accelerated by external source of heat and air. Few of such commonly used chemicals, having incompatibility with each other are:
i) Chromic acid with flammable solvents, such as acetone, alcohols, hydrocarbons etc.
ii) Potassium permanganate with con. Sulphuric acid.
iii) Con. Nitric acid with organic solvents and any organic mass.
iv) Con. Hydrogen peroxide solution with flammable solvents.
v) Sodium hydride, elements like sodium, potassium lithium etc. with water.
Many of fire investigations have proved beyond doubt that the cause of fire in most of the cases was due to neglect, poor house keeping practices, accumulation of flammable wastes such as cotton rags, residual oil and grease etc.
iii) Sparks:
Sparks may be produced from various sources, such as from electric motors, switches, loose electric connections or by static electric discharges. Sparks are also generated from friction between mechanical parts, by hammering and chiseling etc. to avoid electric sparking, some of the recommended precautions are:
i) All the electrical fittings, such as switches, lighting, induction motors etc. should be flameproof in nature.
ii) Electric panels, main control switches etc must be away from the process block.
iii) Electric cables/wires connected to equipments should be of the right quality and should be in one piece (there should not be any joints on the cable).
iv) Proper earthing should be provided to all equipments, storage vessels etc.
v) No flammable solvents must be stored or collected in non-conducting containers (such as plastic buckets, PVC/HDPE containers etc.).
Similarly, sparks produced by mechanical operations can be contained to a great extent by adopting following precautions:
i) All moving parts of the mechanical equipment, such as the shaft of the gear box, shaft of the fan in a drying oven, clutches of a centrifuge etc must be greased and maintained in good condition.
ii) Hammering and chiseling should be avoided as far as possible inside the process plant.
If at all they have to be done, use hammers / chisles made of brass or gun metal, which does not produce sparks on hammering.
a) Static Electric Discharge:
This is a phenomena in which certain products, mostly of organic liquids and non-polar solvents get electrically charged on their surface, by virtue of factors, such as high speed discharge, fall from heights, separation at a higher speed, prolonged storage etc. Causes for fire in many industries especially chemical and paper, are attributed to this unique phenomena. Most of these occur during the months when the atmospheric hu