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WHO GMP Certification M. Mitra CDSCO(NZ)

WHO GMP Certification M. Mitra CDSCO(NZ). WHO GMP CERTIFICATION. Originally promugulated in 1969 and revised in 1975. Main objectives were : Guidelines be developed for official inspections of dug manufacturing facilities

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WHO GMP Certification M. Mitra CDSCO(NZ)

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  1. WHO GMP CertificationM. Mitra CDSCO(NZ)

  2. 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 Cochin-05

  3. WHO GMP CERTIFICATION • 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. Cochin-05

  4. 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. Cochin-05

  5. WHO GMP CERTIFICATION • There are more than 600 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 the fourth largest exporter of Drugs & Pharmaceuticals Globally. • Other purchasers like the State governments, ESI etc. have also started (erroneously) asking for the certificates as preconditions. Cochin-05

  6. WHO GMP CERTIFICATION Understanding WHO GMP Documents and Literature Cochin-05

  7. A series of reports known as the WHO Technical Report Series (TRS) are available. TRS 823 (1992) TRS 863 (1996) TRS 885 (1999) TRS 902 (2002) TRS 908 (2003) TRS 917 (2004) WHO GMP CERTIFICATION Cochin-05

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  9. WHO GMP CERTIFICATION 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 Cochin-05

  10. WHO GMP CERTIFICATION Issue of Certificates What are the 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) There is another Certificate – Site Certificate. Described later Cochin-05

  11. WHO GMP CERTIFICATION 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. Cochin-05

  12. WHO GMP CERTIFICATION Conditions to be satisfied before opting for the scheme by any member country • Effective national licensing system for products, manufacturers and distributors • WHO GMP norms are in place for manufacturers • 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 Cochin-05

  13. WHO GMP CERTIFICATION • COPP is issued when the product in question is under consideration for a product license that will authorize its importation and sale and when administrative action is required for renew, extend, vary or review s such a license. • All requests through agents in the importing country and product license holder or agent in the exporting country Applicant should submit the following: • Brand name • Generic name or INN • Name and address of manufacturing facility • Formulation • Product information for medical professionals and patients as approved by the authority • Labeling in retail and wholesale containers, and • Retail packaging Cochin-05

  14. WHO GMP CERTIFICATION • The certificate is a confidential document and can only be issued with the permission of the applicant by the competent authority of the exporting country • The COPP is intended to be incorporated in the product license application in the importing country. The COPP is transmitted by the applicant or agent in the importing country • In case of doubt Competent authority can directly request a certificate from the issuing authority • In the absence of any agreement, COPP shall be prepared in the working language of the issuing country. The applicant is responsible for providing notarized translations if required • Due to significant administrative load, charges may be levied by the issuing authority Cochin-05

  15. WHO GMP CERTIFICATION The Certificate TRS 863 Appendix 1 Model Certificate of a Pharmaceutical Product C:\Documents and Settings\Administrator\My Documents\Appendix 1.doc Cochin-05

  16. WHO GMP CERTIFICATION Understanding the Technical Report Series • TRS 823 – Salient features PART I Quality Management in the Drug Industry – Philosophy & Essential Elements • Quality Assurance • Good Manufacturing Practice • Quality Control • Sanitation & Hygiene • Validation • Complaints Cochin-05

  17. WHO GMP CERTIFICATION PART I contd. • Product recalls • Contract Production & Analysis • Personnel • Premises • Material • Documentation Cochin-05

  18. WHO GMP CERTIFICATION • PART II : Good Practices – Production & Quality Control • Good Practices in Production • Good Practices in Quality Control Cochin-05

  19. WHO GMP CERTIFICATION • PART III: Supporting and Supplementary Guidelines • Sterile pharmaceutical Products • Good Manufacturing Practice for Active Pharmaceutical Ingredients A Model Certificate Format is also presented Cochin-05

  20. WHO GMP CERTIFICATION • TRS 863 – Salient features • Guidelines for Stability Testing • Guidelines for Validation • Import Procedure for Drugs • Guidelines for implementation of the Scheme (including model certificate) Cochin-05

  21. WHO GMP CERTIFICATION • TRS 885 – Salient features • GMP – Authorised Persons - Role, Functions & Training • GMP – Supplementary Guidelines for the Manufacture of Pharmaceutical Excepients Cochin-05

  22. WHO GMP CERTIFICATION • TRS 902 – Salient features • Good Practices for National Control Laboratories • GMP for Sterile Products – revision • Inspections • National GMP Inspectorate • Guidelines on Packaging of Pharmaceutical Products • Storage areas • Labels Cochin-05

  23. WHO GMP CERTIFICATION • TRS 908 – Salient features • GMP for Pharmaceutical Products • Main principles • HACCP • Model Certificate of a Pharmaceutical Product • Site Certificate – does not replace the Product certificate Cochin-05

  24. WHO GMP CERTIFICATION • TRS 917 – Salient features • Active Pharmaceutical Ingredients API • Herbal Cochin-05

  25. 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 Cochin-05

  26. WHO GMP CERTIFICATION • 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 Cochin-05

  27. WHO GMP CERTIFICATION • Requirements • Procedures Main Requirements • Product • Procedures • Facilities Cochin-05

  28. WHO GMP CERTIFICATION • Requirements • Product The basic requirements of the product are: • Product design • Stability Studies • Process validation Cochin-05

  29. WHO GMP CERTIFICATION • Requirements • Procedures All actions taken in the facility which leads to the production of the final product as per specification. Cochin-05

  30. WHO GMP CERTIFICATION • Requirements • Facilities This encompasses the building, machinery, services and utilities, manpower etc. These are guided towards making a properly designed product. Cochin-05

  31. WHO GMP CERTIFICATION • GMP Requirements Discussions: 1. Quality Management 2. Sanitation and hygiene 3. Validation 4. Complaints and recalls 5. Contract production and analysis Cochin-05

  32. WHO GMP CERTIFICATION Discussions: 6. Self Inspection 7. Personnel 8. Premises 9. Equipment 10. Materials Cochin-05

  33. WHO GMP CERTIFICATION Discussions: 11. Documentation 12. Sterile production 13. Active pharmaceutical ingredients Cochin-05

  34. WHO GMP CERTIFICATION • 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. Cochin-05

  35. WHO GMP CERTIFICATION • 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 Cochin-05

  36. WHO GMP CERTIFICATION WHO GMP ensures the following: • Avoidance of Cross- Contamination • Prevention of Mix-ups • Provide Traceability • Accountability of actions • Responsibility • Product Performance Guarantee Cochin-05

  37. WHO GMP CERTIFICATION Management Policies TricksRemedies • Time-wasting Threaten to extend inspection • Side-tracking Stick to programme • Provocation Remain calm • Samples provided Select your own sample • Special case Take notes and keep looking Cochin-05

  38. WHO GMP CERTIFICATION Management Policies-II TricksRemedies • Circular argument Recognize and stop • Trial of strength Be firm; know your facts • Insincerity Ignore it • Pity Sympathize; carry on • Absentees Call for deputy • Amnesia Go back and get it yourself Cochin-05

  39. WHO GMP CERTIFICATION • Usual Problems faced by Regulatory Agencies: • Lack of knowledge on the part of applicants • Lethargic mindset • Back to original condition after Certification • Usual Problems faced by applicants: • Sometimes lack of Knowledge on the part of auditors • Teacher as well as Examiner status • Lack of time for thorough auditing Cochin-05

  40. WHO GMP CERTIFICATION • Useful Web Sites: • http://www.who.int/en/ • http://www.who.int/bookorders/anglais/ subscription1.jsp?sesslan=1 • http://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/ Cochin-05

  41. WHO GMP CERTIFICATION Thank You Cochin-05

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