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The purpose of the GxP quality guidelines is to ensure a product is safe and meets its intended use. GxP guides quality manufacture in regulated industries including food, drugs, medical devices, and cosmetics. The most central aspects of GxP are Good Documentation Practices (GDP), which are expected to be ALCOA:
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.
Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following:
A predicate rule is any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11. [3] The rule also applies to submissions made to the FDA in electronic format (e.g., a New Drug Application) but not to paper submissions by electronic methods (i.e., faxes). It ...
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. The second edition (GAMP5) was released in July 2022. [2]
The FDA (Food and Drug Administration) is the US government agency responsible for regulating food, drugs, medical devices, and cosmetics to ensure they are safe and effective.
The FDA's new rules released Thursday essentially set a minimum amount of information mammogram providers will be required to tell women. It "provides uniform guidance," Burstein said, because "it ...
In June 2016, Alcoa Inc. announced plans to split itself into two companies: Alcoa Inc would be renamed as Arconic and would take over the business of designing and building processed metal parts, primarily for the automotive and aerospace industries; a new company, Alcoa Corporation, would be set up and spun out of the remainder of Alcoa Inc ...