View the PDF for 21 CFR Part 211; These links go to the official, published CFR, which is updated annually. As a result, it may not include the most recent changes applied to the CFR. Learn more.

2024年8月30日 · For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). § 211.1 - Scope. § 211.3 - Definitions. § 211.22 - Responsibilities of quality control...

View Title 21 on govinfo.gov; View the PDF for 21 CFR Part 211; These links go to the official, published CFR, which is updated annually. As a result, it may not include the most recent changes applied to the CFR. Learn more.

The regulations set forth in this part and in Parts 211 through 226 of this chapter contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to safety, a...

Sec. 211.122 Materials examination and usage criteria. (a) There shall be written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling,...

title 21 - food and drugs chapter i - food and drug administration, department of health and human services (continued) subchapter c - drugs: general part 211 - current good manufacturing practice for finished pharmaceuticals

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)

part 211 - current good manufacturing practice for finished pharmaceuticals . authority: 21 u.s.c. 321, 351, 352, 355, 360b, 371, 374; 42 u.s.c. 216, 262, 263a, 264. Source: 43 FR 45077, Sept. 29, 1978, unless otherwise noted.

person to perform the assigned functions. Training shall be in the particular op-erations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures re-quired by these regulations) as t. packing, or holding of each drug p.

2023年10月19日 · The Q&As generally clarify the existing CGMP regulations for finished pharmaceuticals: 21 CFR part 211 Questions and Answers on Specific Topics: General Provisions