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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 ]
NPA GMP Certification is awarded to companies that comply with the NPA GMP standard as verified through comprehensive third-party inspections of facilities and GMP-related documentation. More than 70 companies are known to have achieved certification. NPA also offers a series of GMP training seminars across the United States each year. [3]
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.
BTEC opened in fall 2007 and was the first facility dedicated to biomanufacturing training. [7] BTEC is 82,500 gross square feet and contains 63,000-gross square feet of laboratories, which range from small or bench scale to large-scale suites that simulate a biomanufacturing pilot plant capable of producing biopharmaceutical products.
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 ...
The main implications in this are that validation should cover all aspects of the process including the application, any hardware that the application uses, any interfaces to other systems, the users, training and documentation as well as the management of the system and the validation itself after the system is put into use.
More specifically, the ISPE's guide The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality. One of the core principles of GAMP is that quality cannot be tested ...
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