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Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages , [ 1 ] cosmetics , [ 2 ] pharmaceutical products , [ 3 ] dietary supplements , [ 4 ] and medical devices . [ 5 ]
GxP is a general abbreviation for the "good practice" quality guidelines and regulations. The "x" stands for the various fields, including the pharmaceutical and food industries, for example good agricultural practice, or GAP.
606 et seq. cGMPs for human blood and blood products; The 700 series includes the limited regulations on cosmetics: 701 Labeling requirements; The 800 series are for medical devices: 803 Medical device reporting; 814 Premarket approval of medical devices [3] 820 et seq. Quality system regulations (analogous to cGMP, but structured like ISO) [4]
Similarly, The Rules Governing Medicinal Products in the European Union, Volume 4, Annex 11: Computerised Systems applies to all forms of computerized systems used as part of a GMP regulated activities and defines Computer System Validation Elements [2]
CGMP is an initialism. It can refer to: cyclic guanosine monophosphate (cGMP) current good manufacturing practice (cGMP) CGMP, Cisco Group Management Protocol, the Cisco version of Internet Group Management Protocol snooping; caseinoglycomacropeptide (CGMP) or caseinomacropeptide; see K-casein; Competitive guaranteed maximum price
Cyclic guanosine monophosphate (cGMP) is a cyclic nucleotide derived from guanosine triphosphate (GTP). cGMP acts as a second messenger much like cyclic AMP.Its most likely mechanism of action is activation of intracellular protein kinases in response to the binding of membrane-impermeable peptide hormones to the external cell surface. [1]
FDA spends fee revenues to hire, support, and maintain personnel for the oversight of these outsourcing facilities. Outsourcing facilities are subject to current good manufacturing practice (CGMP) requirements under section 501(a)(2)(B) of the FD&C Act and will be inspected by FDA on a risk-based schedule (see sections 503B(a) and 503B(b)(4)).