who gmp certification scheme m. mitra former dy. drugs controller (i), cdsco, hq, new delhi
TRANSCRIPT
WHO GMP Certification WHO GMP Certification SchemeScheme
M. MitraFormer Dy. Drugs Controller (I),
CDSCO, HQ, New Delhi
WHO GMP CERTIFICATION Originally promugulated in 1969 and revised in
1975. Main objectives were :
Guidelines be developed for official inspections of dug manufacturing facilities
To assess compliance of GMP
This would facilitate implementation of the scheme
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WHO GMP CERTIFICATION
With 191 countries members in the scheme a solution was found for international commerce between these countries. The scheme offered a solution for those countries which did not have a developed regulatory agency yet wanted to import drugs.
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Basic principles of WHO Good Manufacturing Practice is similar to any established GMP requirement. Allied documents like Schedule M, CFRs, ASEAN GMP, etc are all similar in nature. Anyone following any established GMP procedure will automatically understand the principles in the other GMP requirements.
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WHO GMP CERTIFICATION
WHO GMP requirements have been developed taking into account the principles in various GMP texts and also considering the requirements of developing countries. These requirements are not for domestic use but for international trade.
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WHO GMP CERTIFICATION
There are around 1000 (?) WHO GMP certified manufacturing establishments in the country, with West Zone leading followed by the South, North and the East Zones.
New Applications are coming in everyday due to increase in exports of drugs, India being a major exporter of Drugs & Pharmaceuticals Globally.
Other purchasers like the State governments, ESI etc. have also started (erroneously) asking for the certificates as preconditions.
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WHO GMP ensures the following:Avoidance of Cross- ContaminationPrevention of Mix-upsProvide TraceabilityAccountability of actionsResponsibilityProduct Performance Guarantee
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Understanding WHO GMP
Documents and Literature
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A series of reports known as the WHO Technical Report Series (TRS) are available.
TRS 823 (1992) TRS 834 (1993) TRS 863 (1996) TRS 885 (1999) TRS 902 (2002) TRS 908 (2003) TRS 917 (2004) TRS 929 (2005) TRS 937 (2006)
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WHO GMP CERTIFICATIONOther documents A WHO Guide to Good Manufacturing
Practice (GMP) Requirements (WHO/VSQ/97.02) (for validation)
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WHO GMP CERTIFICATIONVarious other documents are available with WHO which is freely available for users. WHO website is the best source for getting information. Similarly documents of other established Regulatory agencies can expand knowledge and understanding
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WHO GMP CERTIFICATION
Issue of CertificatesWhat are the Certificates?
Three types of Certificates are recommended by the WHO.
These are:1) Product Certificate (COPP) (TRS 823,
863)2) Statement of Licensing Status (TRS 823,
863)3) Batch Certificate (TRS 823,
863)There is another Certificate – Site Certificate.
Described later
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WHO GMP CERTIFICATION
The member state shall attest the following conditions of a manufacturer if required to attest a product for the certification:
1. A specific product is authorized to be placed in the market of the exporting country, if not why not
2. The manufacturing plant is subject to regular inspections for WHO GMP compliance
3. All product information, including labeling is currently authorized in the certifying country.
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Conditions to be satisfied before opting for the scheme by any member country
Effective national licensing system for products, manufacturers and distributor
Effective control of quality of products, including independent laboratory
A technically competent, experienced, resourceful National Pharmaceutical inspectorate, as part of NDRA having legal powers for investigations
Administrative capacity to issue Certificates and quickly notify WHO and other member countries
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Understanding the Technical Report SeriesTRS 823 – Salient features
PART I Quality Management in the Drug Industry – Philosophy & Essential Elements
Quality AssuranceGood Manufacturing PracticeQuality ControlSanitation & HygieneValidationComplaints
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WHO GMP CERTIFICATIONPART I contd.Product recallsContract Production & AnalysisSelf-inspection and quality auditsPersonnel (including key personnel)Equipment PremisesMaterialDocumentation
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WHO GMP CERTIFICATIONPART II : Good Practices – Production & Quality Control
Good Practices in Production Includes General requirements, prevention of cross
contamination and bacterial contamination, processing operations, packaging operations
Good Practices in Quality Control Control of starting material and intermediate, bulk,
and finished products, test requirements, production record review, stability studies
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PART III: Supporting and Supplementary Guidelines
Sterile pharmaceutical Products General requirements (air classifications), manufacture of sterile
preps, personnel, premises, equipment, sanitation, processing, sterilization, filtration, finishing, quality control,
Good Manufacturing Practice for Active Pharmaceutical Ingredients
Explanation, general considerations, personnel, premises, equipment, sanitation, documentation, retention of records and ref samples, production,
Form and content of inspector’s reportValidation of analytical procedures
A Model Certificate Format is also presented
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TRS 863 – Salient featuresUseful guidelines:Guidelines for Stability TestingGuidelines for ValidationImport Procedure for DrugsGuidelines for implementation of the Scheme
(including model certificate)Guidelines on import procedures for
pharmaceutical products
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TRS 885 – Salient featuresGMP – Authorised Persons - Role, Functions &
TrainingRole and position of authorized person, implementation of the quality system, education and training., routine duties of an authorized person,
GMP – Supplementary Guidelines for the Manufacture of Pharmaceutical ExcepientGeneral considerations, self inspection and quality audits, use of equipment, cleaning programme, starting material, rejected and recovered materials, returned excepients, storage practices, specifications, BPRs, change control and process validation, prevention of cross contamination, blending, microbial contamination, water systems, packaging, quality control etc.
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TRS 902 – Salient features
Good Practices for National Control Laboratories
Basic elements of GMP (definition) GMP for Sterile Products – revision Inspections National GMP Inspectorate Guidelines on Packaging of Pharmaceutical Products Storage areas Labels
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TRS 908 – Salient featuresGMP for radio pharmaceuticals
GMP for Pharmaceutical Products Main principles
HACCPGuidance on GMP: Inspection reportGuide to good storage practices for pharmaceuticals
Model Certificate of a Pharmaceutical ProductSite Certificate – does not replace the Product certificate
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TRS 917 – Salient features
Active Pharmaceutical Ingredients API
Herbal
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Concept of sampling of starting materialsHeating ventilation and air conditioningValidationWater for pharmaceutical use
..\GMP matters\WHO_TRS_929.pdf
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TRS 929 – Salient features
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One of the most important TRS Supplementary guidelines on GMP for HVAC (Supplementary guidelines on GMP for Herbals) Supplementary guidelines on GMP : Validation
HVAC Water Systems Cleaning Analytical Method Computerized Systems Qualification of systems and equipment Non-sterile process validation
Good Distribution Practices for pharmaceutical products
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TRS 937 – Salient features
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WHO GMP CERTIFICATION
How to Certify a Product
Certification of products are done after thorough examination of the product and the facilities where these are manufactured
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How to Certify a Product
The facilities are Inspected NRA Inspectors with good knowledge of GMP
The inspection may take two or more days
Certificates are issued by the Issuing Authority on the recommendation of the joint report
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WHO GMP CERTIFICATION Requirements
Procedures Main Requirements
A. ProductB. ProceduresC. Facilities
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WHO GMP CERTIFICATION
Requirements
A. Product
The basic requirements of the product are:
1. Product design
2. Stability Studies
3. Process validation
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Requirements
B. Procedures
All actions taken in the facility which leads to the production of the final product as per specification.
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Requirements
C. Facilities This encompasses the building,
machinery, services and utilities, manpower etc. These are guided towards making a properly designed product.
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WHO GMP CERTIFICATION Inspection Points1. Quality Management 2. Sanitation and hygiene3. Validation 4. Complaints and recalls 5. Contract production and analysis6. Self Inspection 7. Personnel
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WHO GMP CERTIFICATIONDiscussions:
8. Premises 9. Equipment
10. Materials
11. Documentation
12. Sterile production 13. Active pharmaceutical ingredients
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WHO GMP CERTIFICATION
GMP consists of various activities which an be grouped together as follows:
1. Training - induction, ongoing, refresher etc.alonwith such documents like SOP, training calendar, assessment etc.
2. Cleaning sanitation and hygiene - may also include workers entry procedure, cleaning of the premises etc
3. Validation and calibration - qualification of machinery, equipment etc.
4. Storage - apart from normal ware-housing facilities, this
should also address quarantine, procedure Etc.
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5. movement of manpower, material - uni-flow movement, movements control
etc.
6. Quality assurance – 7. Quality control8. Documentation - must include MFR, BPR, SOP Documents
control & distribution, cleaning, training, and document regulating and recording other activities
9. Change control – 10. Self inspections and audits
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Usual Problems faced by Regulatory Agencies:Fund problemsLack of knowledge on the part of applicantsLethargic mindsetBack to original condition after CertificationUsual Problems faced by applicants:Sometimes lack of Knowledge on the part of auditorsTeacher as well as Examiner statusLack of time for thorough auditing
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Useful Web Sites: http://www.who.int/en/http://www.who.int/bookorders/anglais/ subscription1.jsp?sesslan=1http://www.who.int/medicines/
organization/
qsm/activities/qualityassurance/gmp/gmpcover.html
http://www.fda.gov/http://www.health.gov.au/tga/docs/
html/gmphome.htm http://www.mca.gov.uk/
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WHO GMP CERTIFICATIONM. MitraFormer Dy. Drugs Controller (India),CDSCO(M) 9716755102Email : [email protected]
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