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The 200 and 300 series are regulations pertaining to pharmaceuticals : 202-203 Drug advertising and marketing; 210 et seq. cGMPs for pharmaceuticals; 310 et seq. Requirements for new drugs; 328 et seq. Specific requirements for over-the-counter (OTC) drugs. The 500 series are regulations for animal feeds and animal medications: 510 et seq. New ...
World Health Organization GMP Guidelines; European Union GMP Guidelines; US CFR Title 21 parts 210 (GMP, general), 211 (GMP, finished pharmaceuticals), 212 (GMP, positron emission tomography drugs), 225 (GMP, medicated feeds), 226 (GMP, type A medicated articles). Report on Optimizing and Leaning GMP Batch Record Design
A few volumes of the CFR at a law library (titles 12–26) In the law of the United States, the Code of Federal Regulations (CFR) is the codification of the general and permanent regulations promulgated by the executive departments and agencies of the federal government of the United States. The CFR is divided into 50 titles that represent ...
For the most uptodate version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).6 New Search Help7 | More About 21CFR 8 [Code of Federal Regulations] [Title 21, Volume 5] [Revised as of April 1, 2015] [CITE: 21CFR314.50] TITLE 21FOOD AND DRUGS CHAPTER IFOOD AND DRUG ADMINISTRATION
Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)).
The U.S. Food and Drug Administration has created draft guidance on data integrity for the pharmaceutical manufacturers required to adhere to U.S. Code of Federal Regulations 21 CFR Parts 210–212. [12] Outside the U.S., similar data integrity guidance has been issued by the United Kingdom (2015), Switzerland (2016), and Australia (2017). [13]
The United States regulations for STCs are found at 14 CFR 21.111. [4]The European Union regulations for STCs are found Commission Regulation (EU) No 748/2012 of 3 August 2012 as amended, Part-21, Subpart E [5] et seq.
All federal programs, recipients, and auditors are required to follow these guidelines. [2] Part IV: Agency Program Requirements – By far the largest section of the Supplement, this section is similar to Part III with the exception that it provides the information program by program in substantial detail. Whereas Part III simply discusses the ...