gmp a quality assurance msrppt

8/12/2019 Gmp a Quality Assurance Msrppt

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GMP & Quality

Assurance

B


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Introduction GMP ensures that quality is built into the

organization & processes involved in

manufacture GMP covers all aspects of manufacture

including collection, transportation,processing, storage, QC & delivery of the

finished product


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GMP Part of QA whichensures that productsare consistently

produced & controlledto the qualitystandards appropriateto their use.

GMP is an integral partof QA.


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QA, GMP & QC inter-

relationshipQA

It is the sum total of the

organized arrangementswith the objective of

ensuring that products willbe of the quality required

for their intended use


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QC & QA Part of GMP which isconcerned withsampling,

specifications,testing and with in theorganization,documentation andrelease procedures

which ensure that thenecessary & relevanttests are carried out

QA is the sum total oforganizedarrangements made

with the object ofensuring that productwill be of the Qualityrequired by theirintended use.


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QC & QA Operationallaboratorytechniques &activities used tofulfill therequirement of

Quality

All those plannedor systematicactions necessaryto provideadequateconfidence that a

product will satisfythe requirementsfor quality


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QC & QA

QC is laboratorybased

QA is companybased


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GMP Good Manufacturing Practice Good Management Practice

Get More Profit Give more Production

GMP Training with out tears


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Ten Principles of GMP

1. Design & construct the facilities & equipmentsproperly2. Follow written procedures & Instructions3. Document work4. Validate work5. Monitor facilities & equipment6. Write step by step operating procedures & work on

instructions7. Design, develop & demonstrate job competence

8. Protect against contamination9. Control components & product related processes10. Conduct planned & periodic audits


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Beyond GMP

Reduce pollution -Zero discharge

Adaptation of environment friendlymethods

Consideration for better & healthier lifetomorrow

Consideration of ethics in life

One should begin with end in mindotherwise it will be the beginning of theend


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List of important documents in

GMP Policies SOP Specifications MFR (Master Formula Record) BMR Manuals Master plans/ files Validation protocols Forms & Formats Records


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How do GMPs of different

countries compare?

At a high level, GMPs of various nations are very

similar; most require things like: Equipment & facilities being properly

designed, maintained, & cleaned

SOPs be written & approved

An independent Quality unit (like QC and/or QA) Well trained personnel & management


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Basic Requirements of

GMP

All manufacturing processes are clearly defined,

systematically reviewed, & shown to be capable ofconsistently manufacturing medicinal products ofthe required quality & complying withspecifications.

Critical steps of the process and significant

changes to the process are validated


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Why GMP is important A poor quality medicine may containtoxic substances that have beenunintentionally added.

A medicine that contains little or noneof the claimed ingredient will not have

the intended therapeutic effect.


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QUALITY

RELATIONSHIPQuality Management

Quality Assurance

G.M.P.

Quality Control

QC

GMP

QA


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BASIC PRINCIPLE OF

QUALITY MANAGEMENT (1)

Manufacturer should ensure the cosmeticproducts comply with the requirements ofASEAN Cosmetic Directives (ACD).

They should also comply with any otherapplicable regulations pertaining to yourspecific country.

The attainment of this quality objectiveshould be led by the senior management &requires the participation and commitmentby staff, by the companys suppliers anddistributors.
http://images.google.com.sg/imgres?imgurl=http://upload.wikimedia.org/wikipedia/id/d/d6/ASEAN.gif&imgrefurl=http://id.wikipedia.org/wiki/ASEAN&h=150&w=150&sz=6&tbnid=YE-v_J-dojoJ:&tbnh=90&tbnw=90&hl=en&start=5&prev=/images%3Fq%3D%2522ASEAN%2522%26svnum%3D10%26hl%3Den%26lr%3D%26sa%3DNhttp://images.google.com.sg/imgres?imgurl=http://upload.wikimedia.org/wikipedia/id/d/d6/ASEAN.gif&imgrefurl=http://id.wikipedia.org/wiki/ASEAN&h=150&w=150&sz=6&tbnid=YE-v_J-dojoJ:&tbnh=90&tbnw=90&hl=en&start=5&prev=/images%3Fq%3D%2522ASEAN%2522%26svnum%3D10%26hl%3Den%26lr%3D%26sa%3DN


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BASIC PRINCIPLE OF

QUALITY MANAGEMENT (2)

To achieve the reliable quality objective, thereshould be a comprehensive QA system

incorporating GMP.

The QA system should be fullydocumented& its effectiveness

should be monitored.


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Principles of Quality

Assurance (QA)

Wide-ranging conceptCovers all matters that individually or

collectively influence the quality of a product

Totality of the arrangementsTo ensure that the drug is of the right qualityfor the intended use

QA incorporates GMP and also product design &

development which is outside thescope of this module


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BASIC REQUIREMENTS OFQA

Ensure that products are designed and developed based onsound scientific rationale and with GMP or GLP principlesbeing taken into consideration.

Ensure that managerial responsibilities are clearly specified. Ensure that production and control operations are clearly

specified and GMP is adopted. Organize supply & use of correct starting & packaging

materials. Ensure that finished products are correctly processed &

checked before release.

Ensure that products are released after review by authorizedperson.

Provide satisfactory arrangement to ensure products arestored, distributed & handled appropriately.

Put in place a mechanism for regular self inspection / internalquality audit.


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GOOD MANUFACURINGPRACTICES

Part of QA which ensures that products areconsistently produced and controlledto the qualitystandards appropriate to their intended use.

Minimize risks :

cross contamination mix up Ensure products/materials are traceable to the

original source. Product testing is not reliable way to assure product

quality. Should BUILD quality into the product! Production and quality control functions should be

independent of each other. All manufacturing process are clearly defined and

systematically reviewed.
http://images.google.com.sg/imgres?imgurl=http://www.kansaigaidai.ac.jp/teachers/shinallj/phrasalverbs/graphics/verb/mixup2.jpg&imgrefurl=http://www.kansaigaidai.ac.jp/teachers/shinallj/phrasalverbs/voc/voc26.html&h=308&w=266&sz=27&tbnid=n5wIqiON5wQJ:&tbnh=112&tbnw=96&hl=en&start=19&prev=/images%3Fq%3D%2522mix%2Bup%2522%26svnum%3D10%26hl%3Den%26lr%3D%26sa%3DGhttp://images.google.com.sg/imgres?imgurl=http://www.kansaigaidai.ac.jp/teachers/shinallj/phrasalverbs/graphics/verb/mixup2.jpg&imgrefurl=http://www.kansaigaidai.ac.jp/teachers/shinallj/phrasalverbs/voc/voc26.html&h=308&w=266&sz=27&tbnid=n5wIqiON5wQJ:&tbnh=112&tbnw=96&hl=en&start=19&prev=/images%3Fq%3D%2522mix%2Bup%2522%26svnum%3D10%26hl%3Den%26lr%3D%26sa%3DG


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All necessary facilities/resources for

GMP should be provided :adequate, qualified and well-trainedpersonnelsuitable premises and sufficient space

suitable locationgood personal hygiene and propersanitationsuitable equipment and services
http://ceoic.com/manage/product/Mixer.jpg


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QUALITY CONTROL

QC is part of GMP.

QC is concerned with sampling, specification and testing.

Manufacturer should have a QC department.

QC should be headed by an appropriately qualified and

experienced person.QC should be independent from production and otherdepartments.

Ensure that the necessary and relevant tests are actuallycarried out.

Ensure that no materials or products will be released forsale or supply, until their quality have been evaluated andjudged to be satisfactory.


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SCOPE OF QC

Items concerned :Starting materials

Packaging materialsBulk productsIntermediate and finished products

Environmental conditions


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BASIC REQUIREMENTS OFQUALITY CONTROL (1)

Adequate facilities, trained personnel and approvedprocedures should be available for sampling,inspecting and testing and, where appropriate,environment monitoring.

Sampling by QC personnel & testing by approvedmethods.

Approved test methods.

Maintenance of QC records &failure investigation records.
http://images.google.com.sg/imgres?imgurl=http://www.tso.co.uk/tso_files/pharmacopoeia1.jpg&imgrefurl=http://www.tso.co.uk/key_products.html&h=213&w=170&sz=4&tbnid=U1QT7t5JIccJ:&tbnh=101&tbnw=80&hl=en&start=4&prev=/images%3Fq%3D%2522British%2Bpharmacopoeia%2522%26svnum%3D10%26hl%3Den%26lr%3D


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BASIC REQUIREMENTS OF

QUALITY CONTROL (2)

Ingredients comply with regulatory specification (grade,composition, strength)

Review and evaluation of production documentation

Assessment of process deviations

Release of batches by authorised person

Sufficient reference samples of starting materials andfinished products


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OTHER DUTIES OF QC

Establish QC procedures

Manage reference standards

Ensure correct labelingStability testing (if applicable)

Complaint investigation

Environmental monitoring


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QUALITY CONTROLACTIVITIES

QC should cover the following:a. Samplingb. Specificationc. Testing

d. Release procedurese. Recalls and complaintsf. Decision making in all quality mattersg. Definition of product qualityh. Laboratory operationsi. Release authorisationj. Investigation and reporting
http://www.elisa-tek.com/Quality%20testing%20small.jpg


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BASIC REQUIREMENTS OFQUALITY CONTROL

Adequate facilities, trained personnel and approvedprocedures should be available for sampling, inspectingand testing and, where appropriate, environmentmonitoring.

Sampling by QC personnel & testing by approvedmethods. Approved test methods. Maintenance of QC records & failure investigation

records. Ingredients comply with regulatory specification

(grade, composition, strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials and

finished products
http://images.google.com.sg/imgres?imgurl=http://www.tso.co.uk/tso_files/pharmacopoeia1.jpg&imgrefurl=http://www.tso.co.uk/key_products.html&h=213&w=170&sz=4&tbnid=U1QT7t5JIccJ:&tbnh=101&tbnw=80&hl=en&start=4&prev=/images%3Fq%3D%2522British%2Bpharmacopoeia%2522%26svnum%3D10%26hl%3Den%26lr%3D


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OTHER DUTIES OF QC

Establish QC procedures

Manage reference standards

Ensure correct labelingStability testing (if applicable)

Complaint investigation

Environmental monitoring
http://images.google.com.sg/imgres?imgurl=http://www.cuyahoga.oh.us/employment/images/investigation.jpg&imgrefurl=http://www.cuyahoga.oh.us/employment/fraud.htm&h=221&w=222&sz=37&tbnid=EuxgtAprixUJ:&tbnh=101&tbnw=102&hl=en&start=1&prev=/images%3Fq%3D%2522investigation%2522%26svnum%3D10%26hl%3Den%26lr%3D%26sa%3DG


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PERSONNEL

Adequate staff with relevant knowledge,experience and capabilities in assigned taska. Production and QC are headed bydifferent persons, neither of whom shallbe responsible to the otherb. Responsibilities and authority of key

personnel are clearly definedc. Training on the understanding ofprocedures, work instruction, GMPprinciples , etc.


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Personnel Qualifications Each person engaged in the manufacture,

processing, packing, or holding of a drug

product shall have education, training, andexperience, or any combination thereof, toenable that person to perform theassigned functions. Training shall be ...


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There are competent and appropriately qualifiedpersonnel in sufficient numbers to ensure serviceprovision. The responsibilities of all staff should be

clearly understood and recorded. All personnel receive initial and continuing

training relevant to their needs.

Only staff who have appropriate training areauthorisedto carry out that procedure. Training should be structured and continuous.

Training records based on SOPs are a goodmeans of evidencing that staff are able toperform tasks.

Competency Assessments can also be usedto assess procedural training.


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3 Key Personnel The head of production The head of QC

The head of QM (QA)


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The head of production

The head of production should be aqualified pharmacist, adequately trained,possess good practical experience in

pharmaceutical manufacture & managerialskill. The head of production should have full

authority & responsibility to manage

production of pharmaceutical products.


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The head of QM (QA)

The head of QM (QA) should be aqualified pharmacist, have adequatetraining & practical experiences which

enable him/her to perform him/herfunction personally.

The head of QM (QA) should given full

authority & responsibility in all qualitysystem/assurance duties.


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PREMISES

Specify the requirements of location, design ,constructions and maintenance of manufacturingpremises with respect to the following:

a. prevention of contamination from surrounding

environment and pestsb. prevention of mix up of materials and products

c. facilities such as toilet, changing rooms, samplingareas and QC lab

d. defined areas for certain activitiese. wall, ceiling, drains , air intake and exhaust,

lighting and ventilation, pipe work and lightfitting

f. storage areas


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Suitable location, design , constructions andmaintenance for manufacturing premises :

defined areas for certain activities (e.gmaterial sampling & dispensing)

wall, ceiling, drains , air intake and

exhaust, lighting and ventilation, pipe workand light fitting

storage areas of adequate space

Physical separation of toilets and QC labfrom production


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Building & facilities1. Design and construction features.2. Lighting.3. Ventilation, air filtration, air heating and

cooling.4. Plumbing.5. Sewage and refuse.6. Washing and toilet facilities.

7. Sanitation.8. Maintenance.


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Paint Finish Not only building

paintwork must be

considered but alsoequipment


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Building Finishes:

In module 1 we discussed the need for allfacility components to complement eachother.

Therefore a good air handling systemmust be complemented by a building ofgood design and good finishes.

On the next slide we will be looking atsome of the Acceptable and Un-acceptable

building finishes.


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Building Finishes

Not Acceptable AcceptablePVA Paint L Epoxy or Enamel paint J

Window sills L Flush glazed windows J

Exposed pipes L Smooth surfaces J

Horizontal pipes & services L Concealed services J

Open floor drains L Hygienic drains J

Floor cracks, flaking floorsurfaces

LHomogonous sealed floors epoxy finish or welded vinyl J

Ceiling cracks & joints L Smooth sealed ceilings J

Exposed, open light fittings L Flush light fittings J

Wooden furniture LS/Steel or Melaminefurniture J


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Design and ConstructionFeatures

Any building or buildingsused in the manufacture,processing, packing, or

holding of a drug productshall be of suitable size,construction, and locationto facilitate cleaning,maintenance, and properoperation.
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Product Areas

Premises should preferablybe laid out in such a way as: To allow the production to take

place in areas connected in a

logical order corresponding tothe sequence of the operations,the requisite cleanliness levels,

To avoid crowding and disorder,

To allow effectivecommunication and supervision.


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Weighing Area The weighing of starting materials and the

estimation of yield by weighing should be

carried out in separate weighing areasspecially designed for that use. Such areasmay be part of either storage orproduction areas.


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Storage Areas

Specify the requirements concerning storage ofmaterials/ products with respect to thefollowing

a. Space, design, security and cleanlinessb. Storage of quarantine stocksc. Storage of hazardous substancesd. Conditions of storage area

e. (e.g. temperature & relative humidity)f. Receiving of incoming materialsg. Stock control (e.g. FIFO principle,h. proper labeling on the container)


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Ventilation, Air Filtration, Air

Heating and CoolingEquipment for adequate control over air

pressure, micro-organisms, dust, humidity,and temperature shall be provided when

appropriate for the manufacture,processing, packing, or holding of a drugproduct.

Air-handling systems for ... penicillin shallbe completely separate from those forother drug products for human use.


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QC Areas

QC laboratories should bedesigned to suit the operationsto be carried out in them.

QC laboratories should be

separated from productionareas. Areas where biological or

radioisotope test methods are

employed should be separatedfrom each other.

ll


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Ancillary Areas

Rest and refreshment rooms should beseparated from production & QClaboratory areas.

Facilities for changing clothes and forwashing and toilet purposes should beeasily accessible & appropriate for the

number of users.


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Thank youfor

Your Kind

Attention

gmp a quality assurance msrppt

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