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12月24日 · For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Note: If you need help accessing information in different file formats, see .

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.

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)

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...

§ 211.82 - Receipt and storage of untested components, drug product containers, and closures. § 211.84 - Testing and approval or rejection of components, drug product containers, and...

Process models can be used at any stage of a drug product’s life cycle, from development to commercial manufacturing. However, this guidance applies to process models that are used as part of a...

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.

(a) The regulations in this part contain the minimum current good manufacturing practice for preparation of drug products (excluding positron emission tomography drugs) for administration to humans or animals.

21 cfr 211 - current good manufacturing practice for finished pharmaceuticals This is the most recent version available on this website. Learn more about the CFR .