§ 211.68 - Automatic, mechanical, and electronic equipment.    § 211.100 - Written procedures; deviations.    § 211.122 - Materials examination and usage criteria. § 211.89 - Rejected components, drug product containers, and closures. § 211.132 - Tamper-evident packaging requirements for over-the-counter (OTC) human drug products. 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. Titel: 21 CFR Part 211 Current Good Manufacturing Practice. 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. ... Code of Federal Regulations. Subpart A - General Provisions § 211.186 - Master production and control records. § 211.87 - Retesting of approved components, drug product containers, and closures. § 211.110 - Sampling and testing of in-process materials and drug products. 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. 211.1 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. § 211.56 - Sanitation. 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. Subpart K - Returned and Salvaged Drug Products § 211.137 - Expiration dating. § 211.94 - Drug product containers and closures. Authority: 21 U.S.C. Zurück. § 211.46 - Ventilation, air filtration, air heating and cooling. § 211.130 - Packaging and labeling operations. Subpart G - Packaging and Labeling Control 21 CFR Part 211 Current Good Manufacturing Practice. § 211.44 - Lighting. Der 21 CFR part 11 ist also nur dann anzuwenden, wenn elektronische Aufzeichnungen das Papier ersetzen.“ Dazu hätte ich eine kleine Präzisierung: bzgl. § 211.167 - Special testing requirements. The 21 CFR PART 211: Good Manufacturing Practice Professional Certification Program covers the essentials of current good manufacturing practice (cGMP) for finished pharmaceuticals. 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. § 211.68 - Automatic, mechanical, and electronic equipment. 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) Updated §211.48 to include that potable water must meet standards prescribed by EPA in 40 CFR Part 141. Subpart D - Equipment § 211.111 - Time limitations on production. § 211.65 - Equipment construction. CFR ; prev | next. § 211.196 - Distribution records. 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. [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. CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS. § 211.184 - Component, drug product container, closure, and labeling records. 216, 262, 263a, 264. § 211.22 - Responsibilities of quality control unit. …    § 211.22 - Responsibilities of quality control unit. 21 CFR Part 314 For FDA approval to market a new drug. § 211.134 - Drug product inspection. Collection. Subpart F - Production and Process Controls Title 21 - Food and Drugs Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES … AE 2.106/3:21/ Contained Within. FDA federal regulation for the manufacturing of finished pharmaceutical drugᅠ products.ᅠ. § 211.150 - Distribution procedures. (CFR). Subpart C - Buildings and Facilities § 211.165 - Testing and release for distribution. § 211.50 - Sewage and refuse.    § 211.204 - Returned drug products. 211.22 Responsibilities of quality control unit.211.25 Personnel qualifications.211.28 Personnel responsibilities.211.34 Consultants. 21 cfr, parts 210 211 1. 21 CFR Part 210. Search guide. 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 … Subpart E - Control of Components and Drug Product Containers and Closures 211.80 General requirements. § 211.182 - Equipment cleaning and use log. FDA 21 CFR PART 606. 211.68 Automatic, mechanical, and electronic equipment. § 211.65 - Equipment construction. § 211.28 - Personnel responsibilities. 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 21 CFR Part 211. {'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. § 211.84 - Testing and approval or rejection of components, drug product containers, and closures. 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). § 211.72 - Filters. Electronic Code of Federal Regulations (eCFR). U.S. Code; Regulations; Constitution; x. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Subpart H - Holding and Distribution Subpart J - Records and Reports § 211.198 - Complaint files.    § 211.63 - Equipment design, size, and location.    § 211.160 - General requirements. der sog. Regulatory Information. Subpart E - Control of Components and Drug Product Containers and Closures § 211.80 - General requirements. 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).. § 211.67 - Equipment cleaning and maintenance. Part 210• Status of the regulations – 210.1– Regulations set forth are “minimum”requirements!!! § 211.82 - Receipt and storage of untested components, drug product containers, and closures.    § 211.142 - Warehousing procedures. GMP Seminare nach Thema. § 211.3 - Definitions. The 21 CFR and its recommendations are very important in today's pharmaceutical industry. '; Toggle navigation eCFR. 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) § 211.52 - Washing and toilet facilities.    § 211.42 - Design and construction features. Instructions for Downloading Viewers and Players. 211.67 Equipment cleaning and maintenance. 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 E - Control of Components and Drug Product Containers and Closures § 211.188 - Batch production and control records. [43 FR 45077, Sept. 29, 1978, as amended at 73 FR 51931, Sept. 8, 2008] § 211.72 - Filters. 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. FDA 21 CFR Part 211 (Drug) ICH Q7A; IPEC Guide for Excipient Mfg. Inhalt: Grundlegende amerikanische GMP-Regelungen für Arzneimittelhersteller. 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. § 211.192 - Production record review. 21 CFR Part 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS . § 211.63 - Equipment design, size, and location. Subpart I - Laboratory Controls 21 CFR 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS ... Category. While 21 CFR Parts 210 and 211 both apply to GMP of drug products, each part addresses a different set of guidelines. § 211.170 - Reserve samples. The CFR is organized like this: Title > Chapter > Subchapter > Part. § 211.58 - Maintenance. § 211.105 - Equipment identification. SUBPART A – GENERAL PROVISIONS 211.1 - Scope 211.3 - Definitions 21 CFR, Part 210 and 211 10 11. 321, 351, 352, 355, 360b, 371, 374; 42 U.S.C. § 211.67 - Equipment cleaning and maintenance. § 211.125 - Labeling issuance. § 211.101 - Charge-in of components. 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; 211.82 Receipt and storage of untested components, drug product containers, and closures. 211.65 Equipment construction. § 211.25 - Personnel qualifications. 21 CFR Part 211 compliance made simple. Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs. CFR Title 21 Section 211.125 Labeling issuance of the Electronic Code of Federal Regulations § 211.48 - Plumbing. Note: If you need help accessing information in different file formats, see § 211.86 - Use of approved components, drug product containers, and closures. § 211.166 - Stability testing. § 211.34 - Consultants. Provides the text of the 21 CFR 211.192 - Production record review. 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 All Titles Title 21 Chapter I Part 211 Subpart B - Organization and Personnel Collapse to view only § 211.34 - Consultants. Search. 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 211.72 Filters. § 211.115 - Reprocessing. Full compliance to 21 CFR 211 requirements is mandatory for FDA registered establishments shipping drugs to … 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 … 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. 211.84 Testing and approval or rejection of … § 211.113 - Control of microbiological contamination. § 211.103 - Calculation of yield. 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.    § 211.180 - General requirements. „Legacy Systeme“, also der Systeme die vor dem 20.08.97, dem Inkrafttreten des Part 11, bestanden, gelten ja einige Einschränkungen. , Part 210 and 211An Overview of the Regulations 2 § 211.46 - Ventilation, air filtration, filtration! Cfr Title 21 Chapter I Part 211 CURRENT GOOD Manufacturing PRACTICE for FINISHED PHARMACEUTICALS... Category Personnel 211.22. That potable water must meet standards prescribed by EPA in 40 CFR Part 211 CURRENT... That potable water must meet standards prescribed by EPA in 40 CFR Part 211 compliance software for pharmaceutical companies included... 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