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). § 211.1 - Scope. § 211.3 - Definitions. § 211.22 - Responsibilities …

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 …

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 …

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)

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 …

2025年1月21日 · The Q&As generally clarify the existing CGMP regulations for finished pharmaceuticals: 21 CFR part 211 Questions and Answers on Specific Topics: General …

Pt. 211 21 CFR Ch. I (4–1–18 Edition) on which more than one item of label-ing is printed. [43 FR 45076, Sept. 29, 1978, as amended at 51 FR 7389, Mar. 3, 1986; 58 FR 41353, Aug. 3, 1993; …

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, …

2022年11月16日 · How do the part 11 regulations and "predicate rule requirements" (in 21 CFR part 211) apply to the electronic records created by computerized laboratory systems and the …