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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 ]
ISPE has published a series of good practice guides for the industry on several topics involved in drug manufacturing. The most well-known is The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture.
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.
Good engineering practice (GEP) is engineering and technical activities that ensure that a company manufactures products of the required quality as expected (e.g., by the relevant regulatory authorities). Good engineering practices are to ensure that the development and/or manufacturing effort consistently generates deliverables that support ...
Quality management software can be integrated with manufacturing execution systems (MES). A MES is a complete, dynamic software system for monitoring, tracking, documenting, and controlling the manufacturing process from raw materials to final products. [14] When combined with QMS, these systems: ensure compliance; enable quality programs ...
In order for a "best practice" to be valid, it must take into account all relevant approaches, since neglecting to do so would lead to inappropriate usage of the term "best." Comparing sample practices may yield a good practice, but may also be altogether unreliable, depending on how the sample was selected. [4]
Good manufacturing practice; Graduate Medical Program; Galápagos Microplate, a geological feature; Transportation. GmP, a category of mixed train in German-speaking ...
Good tissue practice (GTP) is one of the "GxP" requirements derived from good manufacturing practice. The rule was written and is enforced by the U.S. Food and Drug Administration (FDA), specifically the Center for Biologics Evaluation and Research .
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