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Current good manufacturing practice sections

Current Good Manufacturing Practice for Finished Pharmaceuticals, Sampling and Testing of In-Process Materials and Drug Products, (1998), CFR, Title 21, Part 211, Volume 4, Section 211.110. [Pg.282]

Current Good Manufacturing Practices for Finished Pharmaceuticals Section 211.25 — Personnel Qualifications... [Pg.120]

Code of Federal Regulations, Title 21,Food and drugs,Part 211,Current good manufacturing practice for finished pharmaceuticals, Subpart I, Laboratory controls, Section 211.166, Stability testing. [Pg.700]

Most applications require that certifications be included with the submission, either in the administrative section of the application or within reports of specific types of data included in the application. These include field copy certifications, debarment certifications, current good manufacturing practice (cGMP) certifications, current good laboratory practice... [Pg.4]

Currently, the CFR Title 21, Current Good Manufacturing Practice (cGMP), part 211, subpart I, entitled Laboratory Controls, section 211.165(e) states that the accuracy, sensitivity, specificity and... [Pg.138]

The dual application of PHS Act requirements (licensing of products and establishments in accordance with 42 ET.S.C. 262, PHS Act section 351) as well as the pharmaceutical current good manufacturing practice (cGMP) regulations derived from the Food, Drug and Cosmetic Act (FD C Act)(21 U.S.C. 374)... [Pg.607]

See other pages where Current good manufacturing practice sections is mentioned: [Pg.11]    [Pg.11]    [Pg.227]    [Pg.629]    [Pg.637]    [Pg.637]    [Pg.179]    [Pg.486]    [Pg.332]    [Pg.13]    [Pg.35]    [Pg.36]    [Pg.45]    [Pg.314]    [Pg.437]    [Pg.697]    [Pg.700]    [Pg.26]    [Pg.243]    [Pg.389]    [Pg.362]    [Pg.520]    [Pg.543]    [Pg.399]    [Pg.117]    [Pg.137]    [Pg.317]    [Pg.345]    [Pg.207]    [Pg.294]    [Pg.591]    [Pg.1942]    [Pg.2783]    [Pg.227]    [Pg.26]    [Pg.190]    [Pg.389]    [Pg.259]   
See also in sourсe #XX -- [ Pg.2783 ]



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