GMP, CSV, FDA, SOP – We Love Acronyms, But What Do They All Mean?


Here’s a little guide to acronyms you’ll run into on this blog, and throughout the pharm, biotech, and med devices industries. Here’s some of my favorites:

ALCOA = Attributable, Legible, Contemporaneous, Original, Accurate

First used by the FDA in bioresearch monitoring inspections to describe requirements for data recorded by researchers, is commonly used to describe requirements for all data, from batch records to validation protocol execution.

SISPQ = Safety, Identify, Strength, Purity, and Quality

Attributes of the drug product which the cGMPs seek to maintain. From the Draft Guidance for Industry, Quality Systems Approach to Pharmaceutical cGMP Regulations, FDA, September, 2004:

“Every pharmaceutical product has established identity, strength, purity and other quality characteristics designed to ensure the required levels of safety and effectiveness. For the purpose of this draft guidance document, the phrase achieving quality means achieving these characteristics for the product.”

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