GMP GUIDELINES. GMP Guides from Industry Organisations. FDA cgmp WHO GMP. cgmp Guide Drugs 21 CFR 210 GAMP. ISPE Technical Guides

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1 FDA cgmp cgmp Guide Drugs 21 CFR 210 cgmp Guide Drugs 21 CFR 211 cgmp Guide Medical Device 21 CFR 808, 812, 820 cgmp Guide Biologics 21 CFR 600, 606, 610 Guideline List Human Drugs Guideline List Biologics Guide to Inspections Warning Letters Electronic Records and Signatures (Part 11) WHO GMP GMP Guides from Industry Organisations GAMP ISPE Technical Guides PDA Technical Report IPEC cgmp Guide APIC Interpretation Pharmacopoeias USP EP ICH cgmp Guide (ICH Q7) APIs PIC/S GMP Guide EC GMP Guide EMA GMP Guides

2 GMP GUIDELINES

3 TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER C--DRUGS: GENERAL PART 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS GMP GUIDELINES Subpart A--General Provisions Scope Definitions. Subpart B--Organization and Personnel Responsibilities of quality control unit Personnel qualifications Personnel responsibilities Consultants. Subpart C--Buildings and Facilities Washing and toilet facilities Sanitation Maintenance Design and construction features Lighting Ventilation, air filtration, air heating and cooling Plumbing Sewage and refuse. Subpart D--Equipment Equipment design, size, and location Equipment construction Equipment cleaning and maintenance Automatic, mechanical, and electronic equipment Filters. Subpart E--Control of Components and Drug Product Containers and Closures General requirements Receipt and storage of untested components, drug product containers, and closures Testing and approval or rejection of components, drug product containers, and closures Use of approved components, drug product containers, and closures Retesting of approved components, drug product containers, and closures Rejected components, drug product containers, and closures Drug product containers and closures. Subpart F--Production and Process Controls

4 Written procedures; deviations Charge-in of components Calculation of yield Equipment identification Sampling and testing of in-process materials and drug products Time limitations on production Control of microbiological contamination Reprocessing. Subpart G--Packaging and Labeling Control Materials examination and usage criteria Labeling issuance Packaging and labeling operations Tamper-evident packaging requirements for over-the-counter (OTC) human drug products Drug product inspection Expiration dating. Subpart H--Holding and Distribution Warehousing procedures Distribution procedures. Subpart I--Laboratory Controls General requirements Testing and release for distribution Stability testing Special testing requirements Reserve samples Laboratory animals Penicillin contamination. Subpart J--Records and Reports General requirements Equipment cleaning and use log Component, drug product container, closure, and labeling records Master production and control records Batch production and control records Production record review Laboratory records Distribution records Complaint files. Subpart K--Returned and Salvaged Drug Products Returned drug products Drug product salvaging.

5 EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines. Volume 4 of "The rules governing medicinal products in the European Union" contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively. Introduction Introduction (7/02/2011) Commission Directive 2003/94/EC, of 8 October 2003, laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use Replacement of Commission Directive 91/356/EC of 13 June 1991 to cover good manufacturing practice of investigational medicinal products. Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products. Part I - Basic Requirements for Medicinal Products Chapter 1 Pharmaceutical Quality System into (into operation since 31 January 2013) Chapter 2 Personnel o Current o Deadline for coming into operation: 16 February 2014 NEW Chapter 3 Premise and Equipment o A revised version of Chapter 3 is in preparation. The public consultation on the proposed draft is currently closed. Chapter 4 Documentation (January 2011) Chapter 5 Production o A revised version of Chapter 5 is in preparation. The public consultation on the proposed draft is currently closed. Chapter 6 Quality Control o A revised version of Chapter 6 is in preparation. The public consultation on the proposed draft is currently closed. Chapter 7 on Outsourced activities (into operation since 31 January 2013) Chapter 7 Contract Manufacture and Analysis Chapter 8 Complaints and Product Recall o A revised version of Chapter 8 is in preparation. The public consultation on the proposed draft is currently closed Chapter 9 Self Inspection Part II - Basic Requirements for Active Substances used as Starting Materials Basic requirements for active substances used as starting materials Part III - GMP related documents Site Master File Q9 Quality Risk Management Q10 Note for Guidance on Pharmaceutical Quality System MRA Batch Certificate Template for the 'written confirmation' for active substances exported to the European Union for medicinal products for human use (Version 2, January 2013)

6 Annexes Annex 1 Manufacture of Sterile Medicinal Products Annex 2 Manufacture of Biological active substances and Medicinal Products for Human Use (into operation since 31 Jan 2013) Annex 3 Manufacture of Radiopharmaceuticals Annex 4 Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products Annex 5 Manufacture of Immunological Veterinary Medicinal Products Annex 6 Manufacture of Medicinal Gases Annex 7 Manufacture of Herbal Medicinal Products Annex 8 Sampling of Starting and Packaging Materials Annex 9 Manufacture of Liquids, Creams and Ointments Annex 10 Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation Annex 11 Computerised Systems (revision January 2011) Annex 12 Use of Ionising Radiation in the Manufacture of Medicinal Products Annex 13 Manufacture of Investigational Medicinal Products Annex 14 Manufacture of Products derived from Human Blood or Human Plasma - May 2011 Annex 15 Qualification and validation Annex 16 Certification by a Qualified person and Batch Release A revised version of Annex 16 is in preparation. Stakeholders are invited to comment on this draft by 5 November 2013 at the latest.

7 Annex 17 Parametric Release Annex 19 Reference and Retention Samples Glossary Glossary Other documents related to GMP Compilation of Community Procedures on Inspections and Exchange of Information updated to include new EU formats and procedures Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03) A revised version of the "Guidelines on Good Distribution Practice of Medicinal Products for Human Use" was published in the Official Journal and will come into operation on 8 September (OJ C 68/01, )

8 WHO GMPs : Production Good manufacturing practice (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP is aimed primarily at diminishing the risks inherent in any pharmaceutical production, which may broadly be categorized in two groups: cross contamination/mix-ups and false labelling. Above all, manufacturers must not place patients at risk due to inadequate safety, quality or efficacy; for this reason, risk assessment has come to play an important role in WHO quality assurance guidelines. WHO good manufacturing practices WHO good manufacturing practices: main principles for pharmaceutical products Annex 3, WHO Technical Report Series 961, 2011 Frequently Asked Questions: Good Manufacturing Practice (GMP) in Pharmaceutical Practice Active pharmaceutical ingredients (bulk drug substances) Annex 2, WHO Technical Report Series 957, 2010 Pharmaceutical excipients Annex 5, WHO Technical Report Series 885, 1999 WHO good manufacturing practices for sterile pharmaceutical products Annex 6, WHO Technical Report Series 961, 2011 Biological products Annex 3, WHO Technical Report Series 822, 1992 WHO good manufacturing practices for blood establishments (jointly with the Expert Committee on Biological Standardization) Annex 4, WHO Technical Report Series 961, 2011 Pharmaceutical products containing hazardous substances Annex 3 WHO Technical Report Series 957, 2010 Investigational pharmaceutical products for clinical trials in humans Annex 7, WHO Technical Report Series 863, 1996 Herbal medicinal products Annex 3, WHO Technical Report Series 937, 2006 Radiopharmaceutical products Annex 3, WHO Technical Report Series 908, 2003 Water for pharmaceutical use Annex 2, WHO Technical Report Series 970, 2012 WHO guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for nonsterile pharmaceutical dosage forms Annex 5, WHO Technical Report Series 961, 2011 Validation Annex 4, WHO Technical Report Series 937, 2006 Risk analysis Application of Hazard Analysis and Critical Control Point (HACCP) Methodology in Pharmaceuticals Annex 7, WHO Technical Report Series 908, 2003 Technology transfer WHO guidelines on transfer of technology in pharmaceutical manufacturing Annex 7, WHO Technical Report Series 961, 2011 Training materials Quality Control laboratory training modules

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