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AR L FESCIENCES819/B Rakanpur Indl. Area, Tal. Kalol, Dist. Gandhinagar, Gujarat-60
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The objective of the company is to
produce wide range of
pharmaceutical formulations like
Tablet and Capsule dosage forms.
OBJECTIVEBuild quality into the
products with
established quality systems with the help of a team of well-trained and
technically qualified, competent & committed
personnel.
BELIEF
AR LIFESCIENCES
BELIEF & OBJECTIVE
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AR LIFESCIENCES is a newly commissioned,
professionally managed Private company.
The location of factory building avoids
contamination from open sewage, drain, public
lavatory or any factory which produces
disagreeable or obnoxious odour or fumes or large
quantity of soot, dust or smoke.
The site is located at Rakanpur, 25 Kms. to the
West of Ahmadabad Railway Station, and
Ahmadabad in Gujarat State of India. The plant
has been designed to meet the requirements of
cGMP (Current Good Manufacturing Practices) as
specified by W.H.O and different guidelines
published from time to time.
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ABOUTUS…
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The building used for the factory is constituted to permit
production of drugs under hygienic conditions. Construction of
buildings ensures protection of product from contamination and
permits efficient cleaning. Entire premises are maintained in a
clean and tidy condition.
The plant is designed in logical order corresponding to the
sequence of the operations and to maintain the requisite
cleanliness levels at all stages of manufacturing operations.
The firm is situated in a pollution free environment of village
Rakanpur. The total area of the plot is about 1408.55 sq.mt and
built up area is approximately 1209.73 sq.mt. The buildings are
consisting of ground floor, first floor and second floor. Ground
floor and first floor is provided for manufacturing operations of tablets and Capsules and Quality Control Department. Second
floor is provided for various utility system like AHU systems &
Water plants.
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ABOUTUS…
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KEY PERSONNEL
(Partners)Qualification : B.Com
Experience : 25 yrs
Mr. Aman Madaan & Mr. Rishi Madaan
(Head QA)Qualification : B.SC (Chemistry)
Experience : 20 yrs
Mr. Jiten Dave
(Head Production [Tablet Section])Qualification : M.SC (Chemistry)
Experience : 15 yrs
Mr. Krishnakumar Singh
(Plant Head )Qualification : B.Com Experience : 20 yrs
Mr. Karan Bist
(Executive QC)Qualification : B.SC (Bio-Chemistry)
Experience : 2 yrs
Mr. Dipen Patel
(Microbiologist QC)Qualification : M.SC (Microbiology)
Experience : 1 yrs
Mr. Shiten Patel
(Executive QA)Qualification : B.Pharm
Experience : 1 yrs
Ms. Jinal Parmar
(Head Production [Capsule Section])Qualification : B.SC (Chemistry)
Experience : 35 yrs
Mr. Uday Raj Singh
(Executive Maintenance & Utility)Qualification : B.E Electrical
Experience : 4 yrs
Mr. Viral Patel
(Executive RM-PM Store)Qualification :M.SC
(Inorganic Chemistry)Experience : 1 yrs
Mr. Pravin Kashid
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Name Designation Qualification Experience
Mr. Aman Madaan & Mr. Rishi Madaan
Partners B.Com 25 Years
Mr. Karan Bist Plant Head B.Com 20 Years
Mr. Jiten Dave Head QA B.SC (Chemistry) 20 Years
Ms. Jinal Parmar Executive QA B.Pharm 1 Year
Mr. Gautam Patel Head QC M.SC (Organic-Chemistry) 4 Years
Mr. Dipen Patel Executive Head QC B.SC (Chemistry) 2 Years
Mr. Shiten Patel Microbiologist QC M.SC (Microbiology) 5 Years
Mr. KrishnaKumar Singh Head Production (Tablet Section) M.SC (Chemistry) 15 Years
Mr. UdayRaj SinghHead Production (Capsule
Section)B.SC (Chemistry)
35 Years
Mr. Viral Patel Executive Maintenance & Utility B.E (Electrical) 4 Years
Mr. Pravin Kashid Executive RM-PM StoreM.SC (Inorganic
Chemistry)1 Year
KEY PERSONNEL
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PLANT INFRASTRUCTURE
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PLANT INFRASTRUCTURE
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❑ AHU System:
▪ We have total 20 No. of Air Handling Units (AHU).
▪ All Critical Manufacturing Processing areas like Sampling, dispensing, Granulation Compression, Coating, Primary packing, capsule filling, polishing ,Sealing where the product is exposed to environment are equipped with HVAC system.
❑ Details of AHUs:
▪ Total 20 air handling unit to maintain & control pre defined environmental parameter
▪ Return Air Mixing Chamber
▪ Pre- Filter chamber:10 micron
▪ Cooling coil chamber
▪ Heater Chamber
▪ Fan chamber
▪ Terminal filter 5.0micron Filter.
▪ Supply Air Chamber
▪ Schedule for routine monitoring and Validation of HVAC parameters like Air velocity, Air changes, Particle count, recovery time, test etc. shall be twice in a year.
PRODUCTION INFRASTRUCTURE INFORMATION
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▪ The quality of water shall be maintained stringently by routine microbiological and chemical tests of R.O. Water and Purified water. Purified water is prepared from R.O. Water. Microbial population in potable water shall be control by chlorination. The microbiological limit for potable water is less than 500 CFU per/ml and absence of pathogens such as E.coli, Salmonella, Staphylococcus aureus and Pseudomonas aeroginosa.
▪ Loop system is installed for purified water distribution. All user points shall be validated by chemical and microbiological testing.
▪ The main source of water is ground water, which is stored in a storage tank of 25000 liter capacity.
▪ Purified water shall be stored in 10000 Liters capacity tank
▪ All supply lines are made up of SS 316
▪ Capacity of water Plant : 500 Liters/Hr
▪ Raw Water and, Purified Water shall be tested as per schedule.
▪ SANITATION: Raw water is supplied by Borewell. Purified water plant shall be sanitized as per schedule by Hydrogen Peroxide dosing. Purified water collected in tank is passed through a filter and U.V. bank. Purified water tank and loop system is sanitized by circulating hot purified water .
WATER SYSTEM
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NMT 1.0 micro
mhoh
5.00 to 7.00
100 CFU/ml
Should be Absent
As per
Specifications
1PH
2Conductivity
3Bacteria
4Fungus
5Other Test
ACCEPTANCE CRITERIA FOR PURIFIED WATER
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WATER SYSTEM
Raw Water Tank
Water Pump
SF ACF HPUV
RO Reject Line
RO Plant 500 LPH
Pure Water Line
RO Water Storage Tank
844 vessel
CationResin
1252 vessel
anions Resin
1054 vessel
CationResin
DM Plant
Pure Water Storage Tank
Water Pump
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AR LIFESCIENCES manufactures stable and therapeutically effective formulations in
independent manufacturing facilities. The
facilities are well-equipped to produce
Tablets and Capsules, manufacturing
facilities is cGMP compliant as per WHO
guidelines having a team of well-trained
professionals that take care of initial
Production planning to the final Quality
Control Testing and Analysis. The team
ensures that the products are manufactured
in accordance with global standards and
customer specifications at all times.
MANUFACTURING FACILITIES
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All manufacturing operations shall be carried out under the
supervision of an adequately qualified and a trained person. All
materials used in the manufacturing shall be verified before
use. According to the operation to be carried out, environment
of the area should be controlled and monitored.
All required process controls shall be carried out as per master
formula record and shall be documented accurately.
Theoretical yield and actual yield at various stages of
production shall be compared. In the event of significant
variation at any stage, further processing should be stopped immediately and the matter should be investigated. In all
stages of processing adequate attention shall be paid to the
problem of cross-contamination.
All sections in the production area are well equipped with latest
modern machineries complies to cGMP norms.
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PRODUCTION
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All the equipment's are made up of S.S 316. Parts
of the equipment, which come in direct contact
with the product, are non-reactive, non-additive
and non-absorptive.
New received equipment for production shall be
qualified before routine use.
All the equipment is being qualified in respect of
IQ, OQ & PQ.
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PRODUCTION [EQUIPEMENT]
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PACKING
▪ Packaging operations shall be performed under strict controls.
Flow of materials, utilization of labors and materials and
packaging operation shall be carefully monitored.
▪ All the deliveries of packaging components received in packaging section are first verified for their correctness. Foils,
Labels, cartons and other components which require pre-coding
with batch number, manufacturing date and expiry date or any
other information are also carefully controlled till the labelling
and packaging operations are completed. The batch details on the labels, other packaging materials are recorded in the BPCR
by the production chemist and records are maintained properly.
▪ Prior to placement of materials on packaging line a line
clearance check by Q.A as stipulated in the SOPs. This shall be done to verify that all packaging materials used for the previous
batch have been removed from the packing line and area and
the equipment to be used have been properly cleaned.
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QUALITY CONTROL
Quality Control Laboratory is
equipped with all required
instruments for Qualitative
and quantitative analysis of
raw materials, in process
control, finished Products.
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QUALITY CONTROL
Functions of Quality Control Laboratory:
▪ Qualitative and Quantitative Analysis of Raw Material and packing material.
▪ Intermediate, bulk and finished product analysis.
▪ Calibration, verification of laboratory equipment.
▪ Analytical Method Validation.
▪ Stability studies analysis on finished product.
▪ Microbiological testing of raw material, finished product,
area Environmental monitoring, Purified water analysis.
▪ Periodic review of Retain sample for finished product &
raw material.
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QUALITYASSURANCE
▪ Adequate facilities, trained personnel and
procedures are available for sampling,
inspecting and testing of starting materials,
packaging materials, and finished products.
▪ Exacting Quality Standards are upheld by a
team of experience scientists aided by modern
instruments and stringent technical review
systems.
▪ The sophisticated instrument like HPLC-LC 10
ATVP from Shimadzu Japan, allows for broad
analysis.
▪ The Ultraviolet-visible spectrophotometer ensures accurate analytical analysis. The
Dissolution Test Apparatus from Tab Machines
work on Timed released formulations.
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QUALITYASSURANCE
▪ Shelf-life of products is evaluated, based on Long term and
Accelerated stability studies, with the help of Humidity control
ovens.
▪ A team comprised of qualified technical people from various disciplines and pharmacists are working towards the objective of
continual improvement in Quality of products in adherence to
the cGMP norms
▪ As a result of adopting an inbuilt system of continuous renewal and upgrading, factory is up-to date in terms of technology.
Premises are laid out in such a way to allow the production to
take place in areas connected in a logical order corresponding
to the sequence of the operations and to the requisite
cleanliness levels.
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QUALITY POLICY
▪ AR LIFESCIENCES always aims to establish and maintain high standards of quality for its products.
▪ Products are manufactured and marketed in compliance
with regulatory standards related to identity, purity, safety
and efficacy through a well-defined quality assurance system.
▪ We ensure the quality of starting and packaging materials
by following Specifications & Standard Test Procedures.
The Quality Control Dept at our Associate Mfg plants is responsible for all sampling & analysis work related to raw
material, in-process and finished goods validation samples
& stability samples and aim at carrying out all
requirements of current Good Laboratory Practices
(cGLPs). We ensure that the incoming, in-process and final inspection is done as per documented procedures.
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QUALITY POLICY
▪ AR LIFESCIENCES shall comply and constantly update with current national and international
Quality Protocols as applicable and continuously
strive for achieving global standards.
▪ Continuous training shall be given to the employees in the organization to enhance their skills in
performing their assigned tasks.
▪ We shall adjust and adapt to the changing needs of
our customers and remain dedicated in our efforts to serve them to the best of our ability.
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DOCUMENTATION & DATA HANDLING
▪ Documents for product and process specifications
shall be formulated and maintained by QA
department, which includes broadly Raw Material
Specifications, Packaging Materials specifications,
Standard Testing Procedures etc.
▪ The records related to the manufacturing and
packing as well as for in-process checks and Q.C.
tests are filed together in Q.A. department.
▪ Supportive documents like microbiological quality of
air, water etc. and other like records of production
Q.C. & Q.A., utilities are maintained with the
respective departments.
▪ Following standard operating procedures carries out
the manufacturing and testing.
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DOCUMENTATION & DATA HANDLING
▪ Standard operating procedures shall be prepared for process,
procedures, operation, cleaning, calibration, validation and all
activities related to the manufacturing operations.
▪ Computer program specifications:
All computerized documentation shall be Carried out by of
Pharmasuite Software.
▪ Validation documents:
Master validation plan and all validation shall be carryout asper standard Operating procedures and as per master plan
and schedule. All data are recorded in a desired format for
recording and related records are available and maintained.
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SELF INSPECTION
▪ Internal audit on all the systems, procedures and
operations shall be regularly conducted in order to
monitor compliance with and the effectiveness of GMP
and Q.A principles in various operations and to allow for
the improvement and corrective measures when required. Self-Inspection shall be performed at least
once in six months at properly spread out intervals. The
audit team shall be consisting of quality assurance,
quality control, production, engineering, store & dispatch
department.
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THANK YOU