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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 ...
The PIC (Pharmaceutical Inspection Convention) was founded in October 1970 by the European Free Trade Association (EFTA), under the title of the Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products.
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]
Image credits: Old-time Photos To learn more about the fascinating world of photography from the past, we got in touch with Ed Padmore, founder of Vintage Photo Lab.Ed was kind enough to have a ...
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.
Birthday suit! Lindsay Lohan took to Instagram on Monday to share a nude selfie ahead of her 33rd birthday on Tuesday. The former "Freaky Friday" star appears to be fully nude -- save for some ...
Washington Commanders running back Austin Ekeler was placed on injured reserve this past weekend after he sustained his second concussion in a span of just two months.
In the UK, computer validation is covered in Annex 11 of the EU GMP regulations (EMEA 2011). The FDA introduced 21 CFR Part 11 for rules on the use of electronic records, electronic signatures (FDA 1997). The FDA regulation is harmonized with ISO 8402:1994, [6] which treats "verification" and "validation" as separate and distinct terms.