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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 regulatory practice (GRP), for the management of regulatory commitments, procedures and documentation; Collectively, these and other good-practice requirements are referred to as "GxP" requirements, all of which follow similar philosophies. Other examples include good guidance practice and good tissue practice.
The documentation surrounding a spreadsheet containing a simple but "GxP" critical calculation should not match that of a Chromatography Data System with 20 Instruments) Determination of a "GxP critical" requirement for a computer system is subjective, and the definition needs to be tailored to the organisation involved.
The FDA requires nonclinical laboratory studies on new drugs, food additives, and chemicals to assess their safety and potential effectiveness in humans in compliance with 21 CFR Part 58, Good Laboratory Practice for Nonclinical Studies under the Federal Food Drug and Cosmetic Act and Public Health Service Act. [16]
GAMP published its first guidance in 1994. Soon afterwards the organization entered into a partnership with ISPE, formally becoming part of ISPE in 2000. GAMP has enjoyed the support of numerous regulatory authorities over the years spanning the United States, Europe, and Japan and is now a recognised good practice worldwide. [5]
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 ...
“It’s super leftist, and I grew up in a really conservative, small-town environment,” Rodgers says. “So, that was fun to, like, have my ideologies tested.” ...
Prior to implementing ISO 14001, an initial review or gap analysis of the organization's processes and products is recommended, to assist in identifying all elements of the current operation, and if possible, future operations, that may interact with the environment, termed "environmental aspects". [14]
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