The 21 CFR PART 211: Good Manufacturing Practice Professional Certification Program covers the essentials of current good manufacturing practice (cGMP) for finished pharmaceuticals. § 211.67 - Equipment cleaning and maintenance. Code of Federal Regulations (annual edition) SuDoc Class Number. Subpart G - Packaging and Labeling Control U.S. Code; Regulations; Constitution; x. 211.68 Automatic, mechanical, and electronic equipment. All Titles Title 21 Chapter I Part 211 Subpart B - Organization and Personnel Collapse to view only § 211.34 - Consultants. § 211.84 - Testing and approval or rejection of components, drug product containers, and closures. 21 CFR Part 210. § 211.166 - Stability testing. Code of Federal Regulations] [Title 21, Volume 4] 米国GMP規則(=CGMP)の対訳文 [Revised as of April 1, 2014] [CITE: 21CFR211] 1. Provides the text of the 21 CFR 211.192 - Production record review. FDA federal regulation for the manufacturing of finished pharmaceutical drugᅠ products.ᅠ. § 211.68 - Automatic, mechanical, and electronic equipment. § 211.101 - Charge-in of components. Subpart C - Buildings and Facilities 211.84 Testing and approval or rejection of … 211.1 Scope – Minimum requirements – Applies to drugs for human use 211.3 Definitions – Those set forth in 210.3 are applicable SUBPART A – GENERAL PROVISIONS 21 CFR, Part 210 and 211 11 12. Collection. Subpart K - Returned and Salvaged Drug Products 211.22 Responsibilities of quality control unit.211.25 Personnel qualifications.211.28 Personnel responsibilities.211.34 Consultants.    § 211.100 - Written procedures; deviations. 21 CFR Part 314 For FDA approval to market a new drug. Subpart D - Equipment § 211.115 - Reprocessing. Inhalt: Grundlegende amerikanische GMP-Regelungen für Arzneimittelhersteller. § 211.111 - Time limitations on production. La CFR 21 part 11 se ocupa especialmente de regular cómo deben aplicarse los registros electrónicos, así como las firmas electrónicas en la gestión de datos en la industria farmacéutica. 211.82 Receipt and storage of untested components, drug product containers, and closures. 21 CFR Part 211 Current Good Manufacturing Practice. 21 CFR Part 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS . [43 FR 45077, Sept. 29, 1978, as amended at 73 FR 51931, Sept. 8, 2008] These laws are codified as Part 11 of Title 21 in the Code of Federal Regulations, or 21 CFR Part 11, or Part 11 for shorthand.    § 211.42 - Design and construction features. ... Code of Federal Regulations. § 211.110 - Sampling and testing of in-process materials and drug products. Titel: 21 CFR Part 211 Current Good Manufacturing Practice. 216, 262, 263a, 264. Subpart F - Production and Process Controls Subpart E - Control of Components and Drug Product Containers and Closures § 211.80 - General requirements. FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES, Subpart A - General Provisions (§§ 211.1 - 211.3), Subpart B - Organization and Personnel (§§ 211.22 - 211.34), Subpart C - Buildings and Facilities (§§ 211.42 - 211.58), Subpart D - Equipment (§§ 211.63 - 211.72), Subpart E - Control of Components and Drug Product Containers and Closures (§§ 211.80 - 211.94), Subpart F - Production and Process Controls (§§ 211.100 - 211.115), Subpart G - Packaging and Labeling Control (§§ 211.122 - 211.137), Subpart H - Holding and Distribution (§§ 211.142 - 211.150), Subpart I - Laboratory Controls (§§ 211.160 - 211.176), Subpart J - Records and Reports (§§ 211.180 - 211.198), Subpart K - Returned and Salvaged Drug Products (§§ 211.204 - 211.208), Part 211. It is divided into three chapters: Chapter I — Food and Drug Administration Chapter II — Drug Enforcement Administration § 211.87 - Retesting of approved components, drug product containers, and closures. FDA 21 CFR Part 820 (Device) The sections of the FDA 21 CFR Part 211 standard: Subpart A – General Provisions; Subpart B – Organization and Personnel; Subpart C – Buildings and Facilities; Subpart D – Equipment; § 211.132 - Tamper-evident packaging requirements for over-the-counter (OTC) human drug products. § 211.170 - Reserve samples. FDA 21 CFR Part 211 (Drug) ICH Q7A; IPEC Guide for Excipient Mfg. „Legacy Systeme“, also der Systeme die vor dem 20.08.97, dem Inkrafttreten des Part 11, bestanden, gelten ja einige Einschränkungen. § 211.184 - Component, drug product container, closure, and labeling records. SUBPART A – GENERAL PROVISIONS 211.1 - Scope 211.3 - Definitions 21 CFR, Part 210 and 211 10 11. § 211.25 - Personnel qualifications. Subpart A - General Provisions § 211.137 - Expiration dating. Regulatory Information. 21 CFR Part 11 is divided into three sub-parts: The General Provisions section discusses the scope of the regulations, when and how it should be implemented, and defines some of the key terms used in the regulations. Subpart I - Laboratory Controls § 211.46 - Ventilation, air filtration, air heating and cooling. The information on this page is current as of April 1 2020. § 211.196 - Distribution records. Search guide. § 211.89 - Rejected components, drug product containers, and closures. 21 cfr, parts 210 211 1. § 211.194 - Laboratory records. § 211.58 - Maintenance. 21 CFR 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS ... Category. 211.67 Equipment cleaning and maintenance. § 211.167 - Special testing requirements. § 211.82 - Receipt and storage of untested components, drug product containers, and closures. § 211.65 - Equipment construction. Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP).. Source: 43 FR 45077, Sept. 29, 1978, unless otherwise noted. § 211.44 - Lighting.    § 211.22 - Responsibilities of quality control unit. 211.72 Filters. Part 210• Status of the regulations – 210.1– Regulations set forth are “minimum”requirements!!! § 211.52 - Washing and toilet facilities. Title 21 of the CFR or the Code of Federal Regulations deals with governing of food and drugs in the United States for three of its governing bodies: The FDA (Food and Drug Administration), DEA (Drug Enforcement Agency) and ONDCP (Office of National Drug Control Policy). Electronic Code of Federal Regulations (eCFR). Full compliance to 21 CFR 211 requirements is mandatory for FDA registered establishments shipping drugs to … § 211.130 - Packaging and labeling operations. § 211.182 - Equipment cleaning and use log. § 211.65 - Equipment construction. Easily meet 21 CFR Part 211 FDA regulations accurately and efficiently with an easy-to-use quality management system. § 211.3 - Definitions. § 211.94 - Drug product containers and closures. 21 CFR 4 - cGMP for Combination Products: GMP Medical Device Master Reference Guide: EU Medical Device Regulation 2017-745: 21 CFR 3, 4, 11, 210/211, 820, ICH Q7 - Combination Product GMP Master: 21 CFR 58, 820 - GLP and QSR: GMP - PAT Handbook: In Vitro Diagnostics Master Handbook: 503B Compounding and Packaging: FDA DEA GMP Master Reference Guide Subpart G - Packaging and Labeling Control § 211.122 - materials examination and criteria... 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