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WHO GMP Certification Scheme M. Mitra Former Dy. Drugs Controller (I), CDSCO, HQ, New WHO GMP Certification Scheme M. Mitra Former Dy. Drugs Controller (I), CDSCO, HQ, New Delhi

Originally promugulated in 1969 and revised in 1975. Main objectives were : WHO GMP Originally promugulated in 1969 and revised in 1975. Main objectives were : WHO GMP CERTIFICATION Ø Guidelines be developed for official inspections of dug manufacturing facilities Ø To assess compliance of GMP This would facilitate implementation of the scheme 3/18/2018 Chennai_12

WHO GMP CERTIFICATION With 191 countries members in the scheme a solution was found 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. 3/18/2018 Chennai_12

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Basic principles of WHO Good Manufacturing Practice is similar to any established GMP 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. WHO GMP CERTIFICATION 3/18/2018 Chennai_12

WHO GMP requirements have been developed taking into account the principles in various GMP 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. WHO GMP CERTIFICATION 3/18/2018 Chennai_12

There around 1000 (? ) WHO GMP certified manufacturing establishments in the country, There 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. WHO GMP CERTIFICATION 3/18/2018 Chennai_12

WHO GMP ensures the following: èAvoidance of Cross- Contamination èPrevention of Mix-ups èProvide Traceability WHO GMP ensures the following: èAvoidance of Cross- Contamination èPrevention of Mix-ups èProvide Traceability èAccountability of actions èResponsibility èProduct Performance Guarantee 3/18/2018 Chennai_12 WHO GMP CERTIFICATION

WHO GMP CERTIFICATION Understanding WHO GMP Documents and Literature 3/18/2018 Chennai_12 WHO GMP CERTIFICATION Understanding WHO GMP Documents and Literature 3/18/2018 Chennai_12

A series of reports known as the WHO Technical Report Series (TRS) are available. A series of reports known as the WHO Technical Report Series (TRS) are available. 3/18/2018 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) Chennai_12 WHO GMP CERTIFICATION

Other documents A WHO Guide to Good Manufacturing Practice (GMP) Requirements (WHO/VSQ/97. 02) (for Other documents A WHO Guide to Good Manufacturing Practice (GMP) Requirements (WHO/VSQ/97. 02) (for validation) WHO GMP CERTIFICATION 3/18/2018 Chennai_12

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Various other documents are available with WHO which is freely available for users. WHO Various 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 WHO GMP CERTIFICATION 3/18/2018 Chennai_12

Issue of Certificates What are the Certificates? Three types of Certificates are recommended by Issue of Certificates What are the Certificates? Three types of Certificates are recommended by the WHO GMP CERTIFICATION 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 3/18/2018 Chennai_12

The member state shall attest the following conditions of a manufacturer if required to 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. WHO GMP CERTIFICATION 3/18/2018 Chennai_12

Conditions to be satisfied before opting for the scheme by any member country WHO Conditions to be satisfied before opting for the scheme by any member country WHO GMP CERTIFICATION ü Effective national licensing system for products, manufacturers and distributor ü Effective control of quality of products, including independent laboratory ü A technically competent, experienced, resourceful National Pharmaceutical inspectorate, as part of NDRA having legal powers for investigations ü Administrative capacity to issue Certificates and quickly notify WHO and other member countries 3/18/2018 Chennai_12

Understanding the Technical Report Series TRS 823 – Salient features WHO GMP CERTIFICATION PART Understanding the Technical Report Series TRS 823 – Salient features WHO GMP CERTIFICATION PART I Quality Management in the Drug Industry – Philosophy & Essential Elements ¶ Quality Assurance ¶ Good Manufacturing Practice ¶ Quality Control ¶ Sanitation & Hygiene ¶ Validation ¶ Complaints 3/18/2018 Chennai_12

PART I contd. ¶Product recalls ¶Contract Production & Analysis ¶Self-inspection and quality audits ¶Personnel PART I contd. ¶Product recalls ¶Contract Production & Analysis ¶Self-inspection and quality audits ¶Personnel (including key personnel) ¶Equipment ¶Premises ¶Material ¶Documentation 3/18/2018 Chennai_12 WHO GMP CERTIFICATION

PART II : Good Practices – Production & Quality Control ¶Good Practices in PART II : Good Practices – Production & Quality Control ¶Good Practices in Production Ø Includes General requirements, prevention of cross contamination and bacterial contamination, processing operations, packaging operations ¶Good Practices in Quality Control Ø 3/18/2018 Control of starting material and intermediate, bulk, and finished products, test requirements, production record review, stability studies Chennai_12 WHO GMP CERTIFICATION

PART III: Supporting and Supplementary Guidelines ¶Sterile pharmaceutical Products WHO GMP CERTIFICATION Ø PART III: Supporting and Supplementary Guidelines ¶Sterile pharmaceutical Products WHO GMP CERTIFICATION Ø 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 Ø Explanation, general considerations, personnel, premises, equipment, sanitation, documentation, retention of records and ref samples, production, ¶Form and content of inspector’s report ¶Validation of analytical procedures A Model Certificate Format is also presented 3/18/2018 Chennai_12

TRS 863 – Salient features Useful guidelines: ØGuidelines for Stability Testing ØGuidelines for TRS 863 – Salient features Useful guidelines: ØGuidelines for Stability Testing ØGuidelines for Validation ØImport Procedure for Drugs ØGuidelines for implementation of the Scheme (including model certificate) ØGuidelines on import procedures for pharmaceutical products WHO GMP CERTIFICATION 3/18/2018 Chennai_12

TRS 885 – Salient features GMP – Authorised Persons - Role, Functions & TRS 885 – Salient features GMP – Authorised Persons - Role, Functions & Training WHO GMP CERTIFICATION Role and position of authorized person, implementation of the quality system, education and training. , routine duties of an authorized person, v. GMP – Supplementary Guidelines for the Manufacture of Pharmaceutical Excepient General 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. 3/18/2018 Chennai_12

TRS 902 – Salient features WHO GMP CERTIFICATION v Good Practices for National TRS 902 – Salient features WHO GMP CERTIFICATION v Good Practices for National Control Laboratories v. Basic elements of GMP (definition) v GMP for Sterile Products – revision v Inspections v National GMP Inspectorate v Guidelines on Packaging of Pharmaceutical Products Ø Storage areas Ø Labels 3/18/2018 Chennai_12

TRS 908 – Salient features GMP for radio pharmaceuticals WHO GMP CERTIFICATION GMP TRS 908 – Salient features GMP for radio pharmaceuticals WHO GMP CERTIFICATION GMP for Pharmaceutical Products Main principles HACCP Guidance on GMP: Inspection report Guide to good storage practices for pharmaceuticals Model Certificate of a Pharmaceutical Product Site Certificate – does not replace the Product certificate 3/18/2018 Chennai_12

TRS 917 – Salient features WHO GMP CERTIFICATION Active Pharmaceutical Ingredients API Herbal TRS 917 – Salient features WHO GMP CERTIFICATION Active Pharmaceutical Ingredients API Herbal 3/18/2018 Chennai_12

TRS 929 – Salient features Concept of sampling of starting materials Heating ventilation and TRS 929 – Salient features Concept of sampling of starting materials Heating ventilation and air conditioning Validation Water for pharmaceutical use. . GMP mattersWHO_TRS_929. pdf 3/18/2018 Chennai_12

TRS 937 – Salient features One of the most important TRS ü Supplementary guidelines TRS 937 – Salient features One of the most important TRS ü Supplementary guidelines on GMP for HVAC ü (Supplementary guidelines on GMP for Herbals) ü Supplementary guidelines on GMP : Validation Ø Ø Ø HVAC Water Systems Cleaning Analytical Method Computerized Systems Qualification of systems and equipment Non-sterile process validation ü Good Distribution Practices for pharmaceutical products 3/18/2018 Chennai_12

WHO GMP CERTIFICATION How to Certify a Product Certification of products are done after 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 3/18/2018 Chennai_12

How to Certify a Product WHO GMP CERTIFICATION å The facilities are Inspected How to Certify a Product WHO GMP CERTIFICATION å The facilities are Inspected NRA Inspectors with good knowledge of GMP å The inspection may take two or more days å Certificates are issued by the Issuing Authority on the recommendation of the joint report 3/18/2018 Chennai_12

Requirements Procedures Main Requirements Product B. Procedures C. Facilities A. 3/18/2018 Chennai_12 WHO GMP Requirements Procedures Main Requirements Product B. Procedures C. Facilities A. 3/18/2018 Chennai_12 WHO GMP CERTIFICATION

Requirements A. Product WHO GMP CERTIFICATION The basic requirements of the product are: Requirements A. Product WHO GMP CERTIFICATION The basic requirements of the product are: 1. 2. 3. 3/18/2018 Product design Stability Studies Process validation Chennai_12

Requirements B. Procedures WHO GMP CERTIFICATION All actions taken in the facility which Requirements B. Procedures WHO GMP CERTIFICATION All actions taken in the facility which leads to the production of the final product as per specification. 3/18/2018 Chennai_12

Requirements WHO GMP CERTIFICATION C. Facilities This encompasses the building, machinery, services and Requirements WHO GMP CERTIFICATION C. Facilities This encompasses the building, machinery, services and utilities, manpower etc. These are guided towards making a properly designed product. 3/18/2018 Chennai_12

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3/18/2018 Inspection Points 1. Quality Management 2. Sanitation and hygiene 3. Validation 4. 3/18/2018 Inspection Points 1. Quality Management 2. Sanitation and hygiene 3. Validation 4. Complaints and recalls 5. Contract production and analysis 6. Self Inspection 7. Personnel Chennai_12 WHO GMP CERTIFICATION

Discussions: 8. Premises 9. Equipment 10. Materials 11. Documentation 12. Sterile production 13. Active Discussions: 8. Premises 9. Equipment 10. Materials 11. Documentation 12. Sterile production 13. Active pharmaceutical ingredients 3/18/2018 Chennai_12 WHO GMP CERTIFICATION

GMP consists of various activities which an be grouped together as follows: WHO GMP consists of various activities which an be grouped together as follows: WHO GMP CERTIFICATION 1. Training - induction, ongoing, refresher etc. alonwith such 2. Cleaning sanitation and hygiene - may also include 3. Validation and calibration - qualification of machinery, 4. Storage - apart from normal ware-housing facilities, this documents like SOP, training calendar, assessment etc. workers entry procedure, cleaning of the premises etc equipment etc. should also address quarantine, procedure Etc. 3/18/2018 Chennai_12

5. 6. 7. 8. movement of manpower, material - uni-flow movement, movements control etc. 5. 6. 7. 8. movement of manpower, material - uni-flow movement, movements control etc. Quality assurance – Quality control Documentation - must include MFR, BPR, SOP Documents cleaning, training, and regulating and recording other 9. Change control – 10. Self inspections and audits 3/18/2018 WHO GMP CERTIFICATION Chennai_12 control & distribution, document activities

Usual Problems faced by Regulatory Agencies: ØFund problems ØLack of knowledge on the Usual Problems faced by Regulatory Agencies: ØFund problems ØLack of knowledge on the part of applicants ØLethargic mindset ØBack to original condition after Certification § Usual Problems faced by applicants: ØSometimes lack of Knowledge on the part of auditors ØTeacher as well as Examiner status ØLack of time for thorough auditing WHO GMP CERTIFICATION 3/18/2018 Chennai_12

Useful Web Sites: http: //www. who. int/en/ http: //www. who. int/bookorders/anglais/ subscription 1. Useful Web Sites: http: //www. who. int/en/ http: //www. who. int/bookorders/anglais/ subscription 1. jsp? sesslan=1 http: //www. who. int/medicines/organization/ qsm/activities/qualityassurance/gmp/g mpcover. html http: //www. fda. gov/ http: //www. health. gov. au/tga/docs/html/gmp home. htm http: //www. mca. gov. uk/ 3/18/2018 WHO GMP CERTIFICATION Chennai_12

M. Mitra Former Dy. Drugs Controller (India), CDSCO (M) 9716755102 Email : gmpro@rediffmail. com M. Mitra Former Dy. Drugs Controller (India), CDSCO (M) 9716755102 Email : gmpro@rediffmail. com 3/18/2018 Chennai_12 WHO GMP CERTIFICATION

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