Indian GMP Certification & WHO GMP Certification

Indian GMP Certification & WHO GMP Certification by Mr. Vishal Shelke

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Sub :- Drug Regulatory Affairs
M.Pharm Sem II
Savitribai Phule Pune University

1. WHO & Indian GMP CERTIFICATION Presented By :- Mr. Vishal D Shelke. M.Pharm Sem – II Guided By :- Dr. S.J. Pawar . Department of Pharmaceutics PDEA’s SGRS College of Pharmacy, Saswad

2. Content Introduction to GMP Principle of GMP WHO GMP Certification Certificates Conditions for Scheme Inspection Indian GMP Certification References

3. What is GMP? Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. A GMP is an important enhancement to your food safety management system, which increases your customers’ confidence in your commitment to trading and producing safe, high quality food.

4. Principles of GMP The 10 Principles of GMP are : • Design and Construct the facilities and equipments properly. • Follow written procedures and Instruction. • Document work. • Validate work. • Monitor facilities and equipment. • Write step by step operating procedures and work on instructions. • Design, develop and demonstrate job competence. • Protect against contamination. • Control components and product related processes. • Conduct planned and periodic audits.

5. Documents need for GMP Certification :- The key sections of GMP set out a range of documents requirements for minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product . • GMP Manual • GMP Procedures • GMP Process Approach • Standard Operating Procedures (SOPs) • Exhibits • Sample Formats / Templates • GMP Audit Checklist

6. WHO GMP Certification It was 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 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.

7. 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 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.

8. 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. WHO GMP ensures the following : Avoidance of Cross- Contamination Prevention of Mix-ups Provide Traceability Accountability of actions Responsibility Product Performance Guarantee

9. Certificates Three types of certificates are recommended by the WHO. These are: Product Certificate (COPP) (TRS 823, 863) Statement of Licensing Status (TRS 823, 863) Batch Certificate (TRS 823, 863)

10. The member state shall attest the following conditions of a manufacturer if required to attest a product for the certification: A specific product is authorized to be placed in the market of the exporting country, if not why not The manufacturing plant is subject to regular inspections for WHO GMP compliance All product information, including labeling is currently authorized in the certifying country.

11. 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

12. PART I Quality Management in the Drug Industry – Philosophy & Essential Elements Quality Assurance Good Manufacturing Practice Quality Control Sanitation & Hygiene Validation Complaints

13. PART 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

14. 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 report Validation of analytical procedures

15. 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

16. How to Certify a Product Certification of products are done after thorough examination of the product and the facilities where these are manufactured 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

17. Requirements Procedures Main Requirements Product Procedures Facilities Product The basic requirements of the product are : Product design Stability Studies Process validation

18. Procedures All actions taken in the facility which leads to the production of the final product as per specification. Facilities This encompasses the building, machinery, services and utilities, manpower etc. These are guided towards making a properly designed product.

19. 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 8. Premises 9. Equipment 10. Materials 11. Documentation 12. Sterile production 13. Active pharmaceutical ingredients

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

21. movement of manpower, material – uni -flow movement, movements control etc. Quality assurance – Quality control Documentation – must include MFR, BPR, SOP Documents control & distribution, cleaning, training, and document regulating and recording other activities Change control – Self inspections and audits

22. GMP Inspections in India  FDA conducts facility inspections for products to be sold in the US  Doesn’t include CTM facilities  Doesn’t include clinical stage products About 100 Indian facilities have been inspected by the FDA Otherwise India relies on local inspectors Indian GMP Certification

23. Pharma companies in India don’t pay taxes for their first ten years  Over 20,000 pharma companies in India  They don’t go through complex certification procedures  FDA only conducts facility inspections for products to be sold in the US

24. GMP Regulations in India  Up to 1970, Schedule M of India’s Drug &Cosmetics Act was in place  Advent of GMP requirements covered the gaps  Regulations were harmful to the small players  Consolidation of Schedule M and GMP put onhold until 2005  Amendment of Schedule M is more lenient  Small and medium size enterprises are still in the process of adopting GMPs

25. Good Design Practices for GMP Pharmaceutical Facilities “Andrew A. Signore, Terry Jacobs” Page No :- 180 – 200 Good Manufacturing Practices for Pharmaceuticals Second Edition “Sidney H. Willig . Murray M. Tuckerman. William S. Hitchings Page No – 150-175 https://slideshare.net https://pharmapathway.com http://www.health.gov.au/tga/docs/html/gmphome.html https://mca.gov.uk References

26. Also available on Youtube! Youtube :- https://youtube.com/vishalshelke99 Instagram :- https://instagram.com/vishal_stagram

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