§ 211.63 - Equipment design, size, and location.    § 211.180 - General requirements. § 211.170 - Reserve samples. Regulatory Information. Part 210• Status of the regulations – 210.1– Regulations set forth are “minimum”requirements!!! Subpart D - Equipment § 211.89 - Rejected components, drug product containers, and closures. [43 FR 45077, Sept. 29, 1978, as amended at 73 FR 51931, Sept. 8, 2008] 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. § 211.67 - Equipment cleaning and maintenance. Updated §211.48 to include that potable water must meet standards prescribed by EPA in 40 CFR Part 141. § 211.115 - Reprocessing. § 211.101 - Charge-in of components. § 211.188 - Batch production and control records. § 211.182 - Equipment cleaning and use log. § 211.130 - Packaging and labeling operations. 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.    § 211.42 - Design and construction features. § 211.111 - Time limitations on production. '; Toggle navigation eCFR. 21 CFR Part 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS . Source: 43 FR 45077, Sept. 29, 1978, unless otherwise noted. The 21 CFR PART 211: Good Manufacturing Practice Professional Certification Program covers the essentials of current good manufacturing practice (cGMP) for finished pharmaceuticals.    § 211.100 - Written procedures; deviations. SUBPART A – GENERAL PROVISIONS 211.1 - Scope 211.3 - Definitions 21 CFR, Part 210 and 211 10 11. § 211.3 - Definitions. Subpart E - Control of Components and Drug Product Containers and Closures § 211.80 - General requirements. U.S. Code of Federal Regulations. CFR 21 Part 11, ESIGN Act, and UETA (US) EMA eSignature Capabilities (EU) eIDAS electronic identification and trust services (EU) Here at GlobalSign, we have created our own bible for complying with CFR 21 Part 11 signature requirements, and it is the free PDF: CFR 21 Part 11 Audit Support -Using GlobalSign’s PDF Signing Certificates. § 211.86 - Use of approved components, drug product containers, and closures. § 211.68 - Automatic, mechanical, and electronic equipment. Zurück. Titel: 21 CFR Part 211 Current Good Manufacturing Practice. FDA federal regulation for the manufacturing of finished pharmaceutical drugᅠ products.ᅠ. Note: If you need help accessing information in different file formats, see 216, 262, 263a, 264. 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.    § 211.204 - Returned drug products. Subpart F - Production and Process Controls § 211.46 - Ventilation, air filtration, air heating and cooling. § 211.50 - Sewage and refuse. 21 CFR Part 211. It is divided into three chapters: Chapter I — Food and Drug Administration Chapter II — Drug Enforcement Administration § 211.208 - Drug product salvaging. Authority: 21 U.S.C. Subpart G - Packaging and Labeling Control § 211.52 - Washing and toilet facilities. § 211.167 - Special testing requirements. CFR Title 21 Section 211.125 Labeling issuance of the Electronic Code of Federal Regulations der sog. § 211.132 - Tamper-evident packaging requirements for over-the-counter (OTC) human drug products. 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 Collection. Inhalt: Grundlegende amerikanische GMP-Regelungen für Arzneimittelhersteller. The CFR is organized like this: Title > Chapter > Subchapter > Part. § 211.103 - Calculation of yield. CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS.    § 211.142 - Warehousing procedures. § 211.48 - Plumbing. 211.72 Filters. 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. § 211.173 - Laboratory animals. 211.82 Receipt and storage of untested components, drug product containers, and closures. All Titles Title 21 Chapter I Part 211 Subpart B - Organization and Personnel Collapse to view only § 211.34 - Consultants. Subpart E - Control of Components and Drug Product Containers and Closures CFR ; prev | next. § 211.105 - Equipment identification. § 211.176 - Penicillin contamination. 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). § 211.137 - Expiration dating. § 211.196 - Distribution records. 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. § 211.28 - Personnel responsibilities.    § 211.122 - Materials examination and usage criteria. § 211.150 - Distribution procedures. § 211.94 - Drug product containers and closures. § 211.186 - Master production and control records. Subpart H - Holding and Distribution Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs. Subpart B - Organization and Personnel 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. Subpart I - Laboratory Controls § 211.84 - Testing and approval or rejection of components, drug product containers, and closures. § 211.165 - Testing and release for distribution. 21 CFR Part 11是指《联邦法规21章》第11款,主要内容涉及电子记录和电子签名。实际应用常以符合FDA 21 CFR Part 11 方式表达,此法规确保了电子数据的有效性和可靠性。食品、医药制造行业多遵照此 … (CFR). U.S. Code; Regulations; Constitution; x. 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. 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). Title 21, part 211 of the Electronic Code of Federal Regulations. AE 2.106/3:21/ Contained Within. § 211.25 - Personnel qualifications. 21 cfr, parts 210 211 1. 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) ... Code of Federal Regulations. § 211.67 - Equipment cleaning and maintenance. Given that, the “21 CFR Part 11” name leaves out a couple of details: • Chapter 1: Part 11 falls under “Chapter I,” which applies to the Food and Drug Administration (FDA) and is largely based on the Food, Drug, and … Code of Federal Regulations (annual edition) SuDoc Class Number. {'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. § 211.198 - Complaint files. Easily meet 21 CFR Part 211 FDA regulations accurately and efficiently with an easy-to-use quality management system. § 211.72 - Filters. 21 CFR Part 211 Current Good Manufacturing Practice. The information on this page is current as of April 1 2020. 21 CFR Part 210. § 211.63 - Equipment design, size, and location. 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. Search guide. § 211.110 - Sampling and testing of in-process materials and drug products. Search. Subpart K - Returned and Salvaged Drug Products § 211.44 - Lighting. § 211.184 - Component, drug product container, closure, and labeling records. § 211.134 - Drug product inspection. § 211.34 - Consultants.    § 211.1 - Scope. § 211.125 - Labeling issuance. 21 CFR Part 211 compliance made simple. Provides the text of the 21 CFR 211.192 - Production record review. § 211.113 - Control of microbiological contamination. The 21 CFR and its recommendations are very important in today's pharmaceutical industry. § 211.166 - Stability testing. Der 21 CFR part 11 ist also nur dann anzuwenden, wenn elektronische Aufzeichnungen das Papier ersetzen.“ Dazu hätte ich eine kleine Präzisierung: bzgl. 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 § 211.65 - Equipment construction. 21 CFR, Parts 210 and 211An Overview of the Regulations 2. 211.22 Responsibilities of quality control unit.211.25 Personnel qualifications.211.28 Personnel responsibilities.211.34 Consultants. 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 C - Buildings and Facilities § 211.194 - Laboratory records. While 21 CFR Parts 210 and 211 both apply to GMP of drug products, each part addresses a different set of guidelines. „Legacy Systeme“, also der Systeme die vor dem 20.08.97, dem Inkrafttreten des Part 11, bestanden, gelten ja einige Einschränkungen. Subpart J - Records and Reports 211.67 Equipment cleaning and maintenance. § 211.56 - Sanitation. 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; 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. 21 CFR Part 314 For FDA approval to market a new drug. § 211.22 - Responsibilities of quality control unit. 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. Instructions for Downloading Viewers and Players. FDA 21 CFR Part 211 (Drug) ICH Q7A; IPEC Guide for Excipient Mfg. FDA 21 CFR PART 606. 21 CFR Part 211 compliance software for pharmaceutical companies is included with QT9™ QMS. GMP Seminare nach Thema. § 211.87 - Retesting of approved components, drug product containers, and closures.    § 211.22 - Responsibilities of quality control unit. 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. Full compliance to 21 CFR 211 requirements is mandatory for FDA registered establishments shipping drugs to … 211.84 Testing and approval or rejection of … 211.65 Equipment construction. § 211.65 - Equipment construction.    § 211.80 - General requirements. 21 CFR 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS ... Category. § 211.68 - Automatic, mechanical, and electronic equipment. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). § 211.72 - Filters. 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