Comparison of Guidelines of Indian GMP with WHO GMP By Dr. Uma Vasireddy, M.Pharm,Ph.D.., Professor and Principal, KIPS ,Wgl, INDIA 1
Comparison of Guidelines of Indian GMP with WHO GMP Outline of Presentation • Introductory Elements • Section wise Comparison of Indian GMP withWHO GMP • Web of Schedule M • Discussion on Significant Differences • Conclusion - spirit of ‘Make in India’ 2
Comparison of Guidelines of Indian GMP with WHO GMP Reference Indian GMP , SCHEDULE M WHO GMP • Drugs and Cosmetics Act 1940 • WHO Good Manufacturing Practices for Pharmaceutical • Drugs and Cosmetics Rules 1945 Products: Main Principles, • Schedule L1 Annex – 2, WHO T echnical Report Series 986, 2014 • Schedule U 3
Comparison of Guidelines of Indian GMP with WHO GMP Implementing Authority Indian GMP , SCHEDULE M WHO GMP • Drugs Control Administration • State Drugs Control (DCA) of each state Administration (DCA) and And Central Drugs Standard Central Drugs Standard Control Organization(CDSCO) Control Organization(CDSCO) through joint inspection of the as Central License Approving facility. Authority (CLAA) for special category of drugs. 4
Comparison of Guidelines of Indian GMP with WHO GMP Historical Background Indian GMP , SCHEDULE M WHO GMP • GMPs prescribed under Schedule M vide • First draft on WHO GMP prepared in GSR 735 (E) dt.24 th June, 1988 1967. (resolution WHA 20.34) • While • Revised text in 1971, (Annex. to 22 nd reviewing the case of large volume parenterals, National Human report) (NHRC) • Rights Commission First version of WHO certificates recommended to bring the Schedule M scheme (resolution WHA 22.50) • Revised version of both certification to the level of international texts. • Schedule M revised on par with WHO‐ scheme & GMP text in 1975 (resolution GMP text, vide notification no.GSR 894 WHA 28.65) • Revised draft of WHO ‐ GMP presented (E) dt.11 th December, 2001. • Applicable to all the drug manufacturing in three parts in 1992 (WHO ‐T RS ‐ 823) • cGMP published as Annex. 3 in WHO units in India w.e.f. 1 ‐ 7 ‐ 2005. TRS No.961, 2011. • Further revised and published on TRS No.986, 2014 5
Comparison of Guidelines of Indian GMP with WHO GMP Main Requirements Indian GMP , SCHEDULE M WHO GMP • WHO good manufacturing practices for Schedule M, Par t‐ I : Good Manufacturing Practices for Premises and Materials pharmaceutical products: main principles ‐ 1. General Requirements Annex 2, WHO T echnical Report Series 986, 2. Warehousing area 2014 3. Production area 4. Ancillary area 1. Pharmaceutical quality system 1. Quality control area 2.Good manufacturing practices for 2. Personnel pharmaceutical products 3. Health, clothing & sanitation of workers 3. Sanitation and hygiene 8. Manufacturing operations and controls 4. Qualification and validation 9. Sanitation in the manufacturing 5. Complaints premises 6. Product recalls 10. Raw materials 7.Contract production, analysis and other 11. Equipment activities 12. Documentation and records 8.Self ‐ inspection, quality audits and 13. Labels and printed materials suppliers audit and approval 14. Quality assurance 15. Self inspection and quality audit 6
Comparison of Guidelines of Indian GMP with WHO GMP Main Requirements (Contd..) Indian GMP , SCHEDULE M WHO GMP • Schedule ‐ M, Par t‐ I: (contd …) • WHO good manufacturing practices for pharmaceutical products: main principles ‐ 16. Quality control system Annex 2, WHO T echnical Report Series 986, 17. Specification 2014 (contd …) 18. Master formula records 19. Packaging records 9. Personnel 20. Batch packaging record 10. Training 21. Batch processing record 11. Personal hygiene 22. Standard operating procedures 12. Premises 23. Reference samples 13. Equipment 24. Reprocessing and recoveries 14. Materials 25. Distribution records 15. Documentation 26. Validation and process validation 16. Good practices in production 27. Product recalls 17. Good practices in quality control 28. Complaints and adverse reactions 29. Site master file 7
Comparison of Guidelines of Indian GMP with WHO GMP Specific Requirements Indian GMP , SCHEDULE M WHO GMP • Part ‐ IA: specific requirements for • WHO good manufacturing practices for manufacture of Sterile Products Sterile Pharmaceutical Products, Annex 6, • Part ‐ IB: specific requirements for TRS961, 2011 • Pharmaceutical Excipients, Annex 5, TRS manufacture of Oral Solid Dosage Forms 885, 1999 • Part ‐IC : specific requirements for • Biological Products, Annex 3, TRS 822, manufacture of Oral Liquids 1992 • Part ‐ID : specific requirements for • Active Pharmaceutical Ingredients (bulk manufacture of T opical Products drug substances), Annex 2, TRS 957, 2010 • Part ‐ IE: specific requirements for • Water for Pharmaceutical use, Annex 2, manufacture of Metered Dosage TRS 970, 2012 • WHO good manufacturing practices for Inhalers • Part ‐ IF: specific requirements for Blood Establishments (jointly with the manufacture of Active Pharmaceutical Expert Committee on Biological Ingredients Standardization), Annex 4, TRS 961, 2011. 8
Comparison of Guidelines of Indian GMP with WHO GMP Specific Requirements (Contd..) Indian GMP , SCHEDULE M WHO GMP • Par t‐ II: Requirements of Plant & • WHO guidelines on good manufacturing Equipment practices for heating, ventilation and air‐ conditioning systems for non ‐ sterile 1. External Preparations pharmaceutical dosage forms , Annex 5, TRS 2. Oral Liquid Preparations 961, 2011 • Validation , Annex 4, TRS 937, 2006 3. T ablets • Guidelines on good manufacturing practices: 4. Powders 5. Capsules validation, Appendix 7, on ‐ sterile process 6. Surgical Dressing validation , Annex 3, TRS 992, 2015 • Risk analysis Application of Hazard Analysis and 7. Ophthalmic Preparations 8. Pessaries & Suppositories Critical Control Point (HACCP) Methodology in 9. Inhalers & Vitralle Pharmaceuticals, Annex 7, TRS 908, 2003 • WHO guidelines on transfer of technology in 10. Repacking of drugs and pharmaceutical chemicals pharmaceutical manufacturing, Annex 7, TRS 11. Parenteral Preparations 961, 2011 • Training materials Quality Control laboratory training modules 9
Comparison of Guidelines of Indian GMP with WHO GMP Section wise Comparison Indian GMP , SCHEDULE M WHO GMP 1. GENERAL REQUIREMENTS 12. Premises 1.Principle. Premises must be located, designed, 1.1. Location and surroundings: constructed, adapted and maintained T o avoid risk of contamination from to suit the operations to be carried out. external environment. General 12.2. The layout and design of premises must 2.Building and premises: Designed, aim to minimize the risk of errors on the quality constructed, adapted and maintained of products. to suit the manufacturing operations 3.Measures should be taken to avoid cross ‐ under hygienic conditions. Shall contamination. confirm the conditions under Factories 4.Premises should be situated in an Act 1948. environment with measures to protect risk of (i) Compatible. causing any contamination of materials. (ii) Adequately provided with 5.Facilitate good sanitation. working space. 6.Ensured that repair and maintenance (iii) Prevent entry of insects etc. operations do not hazard to the quality of products. 10
Comparison of Guidelines of Indian GMP with WHO GMP Section wise Comparison (Contd..) Indian GMP , SCHEDULE M WHO GMP GENERAL REQUIREMENTS 12. Premises 1.2. Building and premises: 12.7. Premises should be cleaned according iv. Proper AHU for maintaining to written procedures. temperature & humidity suitable to 8.Electrical supply, lighting, temperature, the comforts of the people working. humidity and ventilation should be v. Provided with drainage system. appropriate during manufacture and vi. The walls & floor be free from storage. cracks; smooth workable. 9.Designed and equipped, against the entry of insects, birds or other animals. 10.Designed to ensure the logical flow of materials and personnel. 1.3 Water System: Validated Water 14. Materials System. 14.6. Water used in the manufacture of pharmaceutical products should be suitable for its intended use. 11
Comparison of Guidelines of Indian GMP with WHO GMP Section wise Comparison (Contd..) Indian GMP , SCHEDULE M WHO GMP 1.4. Disposal of waste: Waste materials (i) Conformity with requirements of 14.44 Provision for the proper and safe Environment Pollution Control Board. storage of waste materials awaiting (ii) Bio ‐ medical waste shall be destroyed disposal. T oxic substances and as per Bio ‐ medical Waste flammable materials should be stored in (Management and Handling) Rules, suitably designed, separate, enclosed 1996. cupboards, as required by national (iii) Additional precautions for rejected legislation. drugs. 14.45 Waste material should not be (iv) Disposal of Hazardous, T oxic substances allowed to accumulate and flammable materials in conformity with Central and State Legislation. 2. Warehousing Area: Storage areas: 2.1. Designed to allow sufficient and 12.15. Sufficient capacity to allow orderly warehousing of various orderly storage of materials. categories of materials and products. 12
Recommend
More recommend
