States Union l European Union EU l U
- Slides: 87
Правила государственного контроля. . . States, Union l European Union (EU) Отдельные главные принципы или рекомендации отдельных стран либо организаций. l U. S. A. l others National and International autorities l PIC/S l FDA Profesiomal organizations l ICH l ISPE l WHO l PDA
Правила ЕС Volume 4 Good Manufacturing practices Medicinal products for human and vererinary use m главные принципы и требования надлежащей практике производства
Code of Federal Regulation Title 21 -Food and Drugs m Правила публикуются в Своде федеральных правил (CFR) и представляют, тем самым, расширение федеральных законов l 210 Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs; general l 211 Current good manufacturing practice for finished pharmaceuticals
Pharmaceutical Inspection Co-operation Schema PIC/S m PIC (Pharmaceutical Inspection Convention) l 1970, EFTA (European Free Trade Association) l „Конвенция о взаимном признании инспекций в отношении производства фармацевтической продукции“ l The Convention for the Mutual Recognition of Inspections in respect of the Manufacture of Pharmaceutical Products
PIC/S m. В ноябре 1995 - PIC Scheme (Pharmaceutical Inspection Co-operation Scheme) как расширение PIC m. PIC Scheme и PIC работают параллельно, неся название PIC/S
PIC/S – countries Country Austria Denmark Finland Iceland Liechtenstein Norway Portugal Sweden Switzerland UK 1971 Hungary Ireland Romania PIC 1971 1971 1971 PIC/S 1999 1995 1996 1995 1999 1996 1999 1976 1977 1982 1995 1996 1995 Country PIC Germany 1983 Italy 1990 Belgium 1991 France 1992 Australia 1993 Netherlands Czech Republic Slovak Republic Spain Canada Singapore Greece Malaysia - PIC/S 2000 1997 1995 1997 1998 1999 2000 2002
PIC/S - Правила m. Правила (guides) l PE 005 -1: GMP Guide for Blood Establishments l PE 007 -1: GMP Guide for Active Pharmaceutical Ingredients - данное руководство соответствует рекомендации ICH Q 7 A
PIC/S - Правила m Рекомендации (recomendations) l PE 012 -1: "Sterility Testing„ l PH 2/95: "Quality System for Official Medicines Control Laboratories„ l PI 002 -1: Quality System Requirements for Pharmaceutical Inspectorates l PI 006 -1: "Validation Master Plan, Installation and Operational Qualification, Non-sterile Process Validation, Cleaning Validation„ l PI 007 -1: "Validation of Aseptic Processes„ l PI 014 -1: Isolators used for Aseptic Processing and Sterility Testing
PIC/S - Правила m СОП и пояснительные указания (explanatory notes) l PI 005 -1: Guidance on Parametric Release l PI 009 -1: Aide-Memoire on the Inspection of Utilities l PI 010 -1: SOP - Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects l PE 008 -1: Explanatory Note for Industry on the Preparation of a Site Master File
FDA - структура Commissioner of Food and Drug CBER CDER Center for Biologics Evaluation and Research Center for Drug Evaluation and Research NCTR CDRH CVM CFSAN National Center for Toxicological Research Center for Devices and Radiological Health Center for Veterinary Medicine Center for Food Safety and Applied Nutrition
FDA –указания по контролю m Biotechnology Inspection Guide m Guide to Inspections of Bulk Pharmaceutical Chemical m Guide to Inspections of High Purity Water Systems m Guide to Inspections of Microbiological Pharmaceutical Quality Control Labs m Guide to Inspections of Pharmaceutical Quality Control Laboratories m Guide to Inspections of Validation of Cleaning Processes m Guide to Inspections of Dosage from Drug Manufacturers-c. GMP’s m Guide to Inspections of Oral Solid Dosage Forms Pre/Post Appr. Issues
FDA –указания по контролю m Guide to Inspections of Sterile Drug Substance Manufacturers m Guide to Inspections of Topical Drug Products m Guide to Inspections of Oral Solutions and Suspensions m Guide to Inspections of Computerised Systems in the Food Processing Industry m Guide to Inspections of Foreign Medical Device Manufacturers m Guide to Inspections of Foreign Pharmaceutical Manufacturers m Inspection Technical Guide
FDA –указания для производителей m Good Laboratory Practice Regulations m Guideline for Submitting Samples and Analytical Data for Methods Validation m Guideline on General Principles of Process Validation m Guideline on Sterile Drug Products Produced by Aseptic Processing m Guideline for Drug Master File
ICH International Conference on Harmonization of Technical Requirements for Registration of Pharmaceutical for Human Use Международная конференция по гармонизации технических требований к регистрации фармацевтической продукции для людей USA EU Japan
ICH m Committee on Proprietary Medicinal Products (CPMP) m European Federation of Pharmaceutical Industries' Associations (EFPIA) m Ministry of Health and Welfare, Japan (MHW) m Japan Pharmaceutical Manufactures of Association (JPMA) m US Food and Drug Administration (FDA) m Pharmaceutical Research and Manufacturers of America (Ph. RMA) существуют: WHO, EFTA и Canada
ICH –указания Q 1 A(R): Stability Testing of New Drugs and Products Q 1 B Photostability Testing Q 1 C: Stability Testing for New Dosage Forms Q 1 D: Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products Q 1 E: Evaluation of Stability Data Q 1 F: Stability Data Package for Registration in Climatic Zones III and IV
ICH –указания Q 2 A Validation of Analytical Procedures: Definitions and Terminology Q 2 B Validation of Analytical Procedures: Methodology Q 3 A(R): Impurities in New Drug Substances Q 3 B(R): Impurities in New Drug Products Q 3 C Impurities: Residual Solvents Q 4: Pharmacopoeial Harmonisation
ICH –указания Q 5 A Q 5 B Q 5 C Q 5 D Q 6 A Q 6 B Q 7 A Viral Safety Evaluation Genetic Stability of Products Cell Substrates Specifications: Chemical Substances Specifications: Biotechnological Substances Good Manufacturing Practice for Active Pharmaceutical Ingredients"
ISPE - Указания Volume 4: Water and Steam Systems Системы воды и пара Volume 5: Commissioning and Qualification Guide Указания по передачи и квалификации
PDA - Technical Reports No. 1 ”Validation of Steam Sterilization Cycles” No. 3 ”Validation of Dry Heat Processes Used for Sterilization and Depyrogenation” No. 8 „Parametric Release of Parenteral Solutions Sterilized by Moist Heat Sterilization” No. 11 ”Sterilization of Parenterals by Gamma Radiation” No. 13 ”Fundamentals of a Microbiological Enviromental Monitoring Program” No. 18 ”Validation of Computer-Related Systems” No. 21 ”Bioburden Recovery Validation” No. 22 ”Process Simulation Testing for Aseptically Filled Products”
PDA - Technical Reports No. 25 "Blend Uniformity Analysis: Validation and IPC“ No. 26 ”Sterilizing Filtration of Liquids” No. 27 ”Pharmaceutical Package Integrity” No. 29 ”Points to Consider Cleaning Validation” No. 30 ”Parametric Release of Sterile Pharmaceuticals Terminally Sterilized by Moist Heat” No. 31 ”Validation and Qualification of Computerized Laboratory Data Acquisition Systems” No. 32 "Auditing of Suppliers Providing Computer Products and Services for Regulated Pharmaceutical Operations” No. 33 „Evaluation, Validation and Implementation of New Microbiological Testing Methods”
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