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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 ]
GAMP itself was founded in 1991 in the United Kingdom to deal with the evolving U.S. Food and Drug Administration expectations for good manufacturing practice (GMP) compliance of manufacturing and related systems. [4] GAMP published its first guidance in 1994.
GCP has been called 'a less morally authoritative document' than the Declaration of Helsinki, lacking moral principles and guidance in the following areas: [6] Disclosure of conflict of interest; Public disclosure of study design; Benefit for populations in which research is conducted; Reporting of accurate results and publication of negative ...
The most central aspects of GxP are Good Documentation Practices (GDP), which are expected to be ALCOA: Attributable: documents are attributable to an individual; Legible: they are readable; Contemporaneously Recorded: not dated in the past or the future, but when the documented task is completed; Original or a True Copy
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.
Some people think using artificial intelligence for so-called "prior authorizations" in the healthcare industry has become too excessive, fuelling public anger at insurance companies. "That's ...
More and more people are talking about polyphasic sleep patterns. But a sleep doctor explains why polyphasic sleep is so unhealthy for humans.
(The Center Square) – An ongoing war in Syria has suddenly ended with the overturning of the long-standing Syrian government, creating national security and humanitarian concerns but also ...