§ 211.176 - Penicillin contamination. AE 2.106/3:21/ Contained Within. § 211.50 - Sewage and refuse. § 211.58 - Maintenance. § 211.105 - Equipment identification. Electronic Code of Federal Regulations (e-CFR) 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; Subpart E - Control of Components and Drug Product Containers and Closures SUBPART A – GENERAL PROVISIONS 211.1 - Scope 211.3 - Definitions 21 CFR, Part 210 and 211 10 11. § 211.167 - Special testing requirements. Subpart D - Equipment Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs. … § 211.137 - Expiration dating. Title 21 - Food and Drugs Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES … The 21 CFR and its recommendations are very important in today's pharmaceutical industry. Titel: 21 CFR Part 211 Current Good Manufacturing Practice. U.S. Code; Regulations; Constitution; x. § 211.111 - Time limitations on production. 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 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) 21 CFR Part 211 compliance made simple. § 211.125 - Labeling issuance. 21 CFR Part 211 Current Good Manufacturing Practice. § 211.166 - Stability testing. U.S. Code of Federal Regulations. Subpart I - Laboratory Controls § 211.134 - Drug product inspection. § 211.72 - Filters. 211.22 Responsibilities of quality control unit.211.25 Personnel qualifications.211.28 Personnel responsibilities.211.34 Consultants.    § 211.80 - General requirements. 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; It is divided into three chapters: Chapter I — Food and Drug Administration Chapter II — Drug Enforcement Administration    § 211.122 - Materials examination and usage criteria. FDA 21 CFR Part 210-211 contains the minimum CGMP for methods to be used in the manufacture, processing, packaging, and holding of drugs to ensure they meet compliance and regulatory requirements, ensuring the safety, quality, and purity of drug products. 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. § 211.113 - Control of microbiological contamination. § 211.67 - Equipment cleaning and maintenance. Title 21, part 211 of the Electronic Code of Federal Regulations. § 211.56 - Sanitation. Search. Full compliance to 21 CFR 211 requirements is mandatory for FDA registered establishments shipping drugs to … Subpart E - Control of Components and Drug Product Containers and Closures Der 21 CFR part 11 ist also nur dann anzuwenden, wenn elektronische Aufzeichnungen das Papier ersetzen.“ Dazu hätte ich eine kleine Präzisierung: bzgl. § 211.173 - Laboratory animals. § 211.65 - Equipment construction. ... Code of Federal Regulations. Instructions for Downloading Viewers and Players. 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 The 21 CFR PART 211: Good Manufacturing Practice Professional Certification Program covers the essentials of current good manufacturing practice (cGMP) for finished pharmaceuticals.    § 211.160 - General requirements. 211.72 Filters. Zurück. § 211.87 - Retesting of approved components, drug product containers, and closures. FDA federal regulation for the manufacturing of finished pharmaceutical drugﾠ products.ﾠ. § 211.170 - Reserve samples. § 211.132 - Tamper-evident packaging requirements for over-the-counter (OTC) human drug products. Note: If you need help accessing information in different file formats, see 321, 351, 352, 355, 360b, 371, 374; 42 U.S.C. 21 CFR Part 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS . 211.65 Equipment construction. Select a CFR Part Number- Use the drop down arrow to select one of the CFR Part Numbers for Title 21 and select Search Regulations.    § 211.1 - Scope. A CFR 21 Parte 11 é obrigatória apenas nos Estados Unidos, porém a norma já vem sendo apontada como tendência e um forte diferencial competitivo para empresas do setor do mundo todo. CFR ; prev | next.    § 211.204 - Returned drug products. § 211.184 - Component, drug product container, closure, and labeling records. § 211.44 - Lighting. Compliance with the 21 CFR 211 guidelines for finished pharmaceuticals is necessary to ensure finished drug products meets the specification in terms of safety, quality, strength, and purity. Subpart H - Holding and Distribution GMP Seminare nach Thema. 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. Subpart E - Control of Components and Drug Product Containers and Closures 211.80 General requirements. 21 CFR, Parts 210 and 211An Overview of the Regulations 2. 211.68 Automatic, mechanical, and electronic equipment. Electronic Code of Federal Regulations (eCFR). § 211.186 - Master production and control records. § 211.52 - Washing and toilet facilities. § 211.68 - Automatic, mechanical, and electronic equipment. Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English, The information on this page is current as of. Subpart J - Records and Reports CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS. § 211.65 - Equipment construction. 英文資料の出典（2015年7月21日に下記アドレスからダウンロードをした資料の訳文である） CFR Title 21 Section 211.125 Labeling issuance of the Electronic Code of Federal Regulations 211.84 Testing and approval or rejection of … § 211.22 - Responsibilities of quality control unit.    § 211.180 - General requirements. § 211.94 - Drug product containers and closures. § 211.188 - Batch production and control records. All Titles Title 21 Chapter I Part 211 Subpart B - Organization and Personnel Collapse to view only § 211.34 - Consultants. Regulatory Information.    § 211.63 - Equipment design, size, and location. 21 CFR 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS ... Category. Search guide. § 211.103 - Calculation of yield. § 211.28 - Personnel responsibilities. § 211.72 - Filters.    § 211.100 - Written procedures; deviations. § 211.198 - Complaint files. Provides the text of the 21 CFR 211.192 - Production record review. § 211.63 - Equipment design, size, and location. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). § 211.130 - Packaging and labeling operations. 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. Subpart F - Production and Process Controls [Code of Federal Regulations] [Title 21, Volume 4] [Revised as of April 1, 2020] [CITE: 21CFR211] TITLE 21--FOOD AND DRUGS ... Records shall be kept of maintenance, cleaning, sanitizing, and inspection as specified in §§ 211.180 and 211.182. 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)..    § 211.22 - Responsibilities of quality control unit.    § 211.142 - Warehousing procedures. der sog. FDA 21 CFR PART 606. 21 CFR Part 211. 211.82 Receipt and storage of untested components, drug product containers, and closures. Updated §211.48 to include that potable water must meet standards prescribed by EPA in 40 CFR Part 141. Subpart E - Control of Components and Drug Product Containers and Closures § 211.80 - General requirements. Inhalt: Grundlegende amerikanische GMP-Regelungen für Arzneimittelhersteller. 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). CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS, Subpart E - Control of Components and Drug Product Containers and Closures, Subpart F - Production and Process Controls, Subpart G - Packaging and Labeling Control, Subpart K - Returned and Salvaged Drug Products, Instructions for Downloading Viewers and Players. § 211.196 - Distribution records. § 211.150 - Distribution procedures. Subpart B - Organization and Personnel § 211.3 - Definitions. § 211.182 - Equipment cleaning and use log. § 211.48 - Plumbing. Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Code of Federal Regulations (annual edition) SuDoc Class Number. § 211.208 - Drug product salvaging. The current good manufacturing practice regulations in 21 CFR 211 also apply to drug products, as describe in 21 CFR 600 through 680 (e.g., biological products, blood products) and human cells, tissues, and cellular and tissue-based products (HCT/Ps) and that are drugs, per 21 CFR 1271 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. Source: 43 FR 45077, Sept. 29, 1978, unless otherwise noted.    § 211.42 - Design and construction features. FDA 21 CFR Part 211 (Drug) ICH Q7A; IPEC Guide for Excipient Mfg. Subpart K - Returned and Salvaged Drug Products Subpart A - General Provisions 21 CFR Part 210. § 211.115 - Reprocessing. {'United States Code': [{'Title': '42', 'Section': '216', 'headtext': ' Regulations', 'cleanpath': '/uscode/text/42/216'}, {'Title': '42', 'Section': '262', 'headtext': ' Regulation of biological products', 'cleanpath': '/uscode/text/42/262'}, {'Title': '42', 'Section': '263a', 'headtext': ' Certification of laboratories', 'cleanpath': '/uscode/text/42/263a'}, {'Title': '42', 'Section': '264', 'headtext': ' Regulations to control communicable diseases', 'cleanpath': '/uscode/text/42/264'}, {'Title': '21', 'Section': '321', 'headtext': ' Definitions; generally', 'cleanpath': '/uscode/text/21/321'}, {'Title': '21', 'Section': '351', 'headtext': ' Adulterated drugs and devices', 'cleanpath': '/uscode/text/21/351'}, {'Title': '21', 'Section': '352', 'headtext': ' Misbranded drugs and devices', 'cleanpath': '/uscode/text/21/352'}, {'Title': '21', 'Section': '355', 'headtext': ' New drugs', 'cleanpath': '/uscode/text/21/355'}, {'Title': '21', 'Section': '360b', 'headtext': ' New animal drugs', 'cleanpath': '/uscode/text/21/360b'}, {'Title': '21', 'Section': '371', 'headtext': ' Regulations and hearings', 'cleanpath': '/uscode/text/21/371'}, {'Title': '21', 'Section': '374', 'headtext': ' Inspection', 'cleanpath': '/uscode/text/21/374'}], 'Statutes at Large': [], 'Public Laws': [], 'Presidential Documents': []}, Electronic Code of Federal Regulations (e-CFR), Chapter I. … 21 CFR 211 - CURRENT GOOD Manufacturing PRACTICE and location Control unit.211.25 Personnel qualifications.211.28 Personnel responsibilities.211.34.! 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