§ 211.196 - Distribution records.
§ 211.22 - Responsibilities of quality control unit.
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.
Updated §211.48 to include that potable water must meet standards prescribed by EPA in 40 CFR Part 141.
§ 211.192 - Production record review. § 211.113 - Control of microbiological contamination.
§ 211.103 - Calculation of yield.
§ 211.72 - Filters.
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). {'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.
Search. „Legacy Systeme“, also der Systeme die vor dem 20.08.97, dem Inkrafttreten des Part 11, bestanden, gelten ja einige Einschränkungen.
§ 211.56 - Sanitation. § 211.22 - Responsibilities of quality control unit. 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).
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.
§ 211.3 - Definitions. (CFR).
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） § 211.48 - Plumbing. § 211.176 - Penicillin contamination.
… 21 CFR 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS ... Category.
Subpart I - Laboratory Controls
CFR ; prev | next. § 211.82 - Receipt and storage of untested components, drug product containers, and closures. 211.22 Responsibilities of quality control unit.211.25 Personnel qualifications.211.28 Personnel responsibilities.211.34 Consultants.
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. § 211.170 - Reserve samples. Regulatory Information. § 211.25 - Personnel qualifications.
21 CFR Part 211. § 211.84 - Testing and approval or rejection of components, drug product containers, and closures.
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. Der 21 CFR part 11 ist also nur dann anzuwenden, wenn elektronische Aufzeichnungen das Papier ersetzen.“ Dazu hätte ich eine kleine Präzisierung: bzgl. § 211.72 - Filters.
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
§ 211.65 - Equipment construction.
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. 211.65 Equipment construction. § 211.150 - Distribution procedures.
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 J - Records and Reports
§ 211.208 - Drug product salvaging. 21 CFR Part 210.
CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS.
Subpart E - Control of Components and Drug Product Containers and Closures 211.80 General requirements.
§ 211.63 - Equipment design, size, and location. Subpart B - Organization and Personnel
21 CFR Part 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS . § 211.80 - General requirements. 21 CFR Part 211 compliance made simple.
[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. [43 FR 45077, Sept. 29, 1978, as amended at 73 FR 51931, Sept. 8, 2008] Subpart K - Returned and Salvaged Drug Products
While 21 CFR Parts 210 and 211 both apply to GMP of drug products, each part addresses a different set of guidelines.
§ 211.68 - Automatic, mechanical, and electronic equipment. § 211.89 - Rejected components, drug product containers, and closures. It is divided into three chapters: Chapter I — Food and Drug Administration Chapter II — Drug Enforcement Administration
§ 211.166 - Stability testing.
211.67 Equipment cleaning and maintenance.
Subpart E - Control of Components and Drug Product Containers and Closures
Subpart C - Buildings and Facilities
§ 211.100 - Written procedures; deviations. 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. Subpart A - General Provisions
§ 211.188 - Batch production and control records. 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. Collection.
§ 211.86 - Use of approved components, drug product containers, and closures.
Authority: 21 U.S.C.
Subpart D - Equipment
§ 211.115 - Reprocessing. § 211.198 - Complaint files.
§ 211.173 - Laboratory animals. All Titles Title 21 Chapter I Part 211 Subpart B - Organization and Personnel Collapse to view only § 211.34 - Consultants. § 211.52 - Washing and toilet facilities.
21 cfr, parts 210 211 1.
§ 211.67 - Equipment cleaning and maintenance. Titel: 21 CFR Part 211 Current Good Manufacturing Practice. § 211.68 - Automatic, mechanical, and electronic equipment. Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs.
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