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August 2010

Nancie Celini

Defining GxP Training and Learning in Life Science Environments: Part 1

Nancie Celini
GxP Learning Program Lead

The bio/pharmaceutical industry has created its own language and GxP is one of many acronyms that we all tend to use. While this may seem "elementary" to some of you, many people may not know what this means. So let's define it because when we refer to "GxP training" you need to have the right context.

  • G = Good
  • x (variable replaced with Clinical, Manfacturing or Laboratory)
  • P = Practice

As you can see, GxP is used as the acronym that refers to the regulations established by the United States Food and Drug Administration which are published in the Code of Federal Regulations. Sometimes people refer to the "GCPs" which specifically were created as the rules that govern clinical trials vs. product manufacturing (GMPs) or laboratory regulations (GLPs). Together, these rules are known collectively as the "predicate rules" and govern a wide spectrum of regulatory obligations across the diverse life science industries. The predicate rules also provide a standard against which citations can be effectively made when FDA inspections are conducted. Violation of a predicate rule will most likely result in a 483 followed by a warning letter. Got it?

There is just a bit more to help you navigate this important terrain before we delve into why a GxP training / learning program is vital. When a regulation is cited, the title tells you where it is published. For example: 21 CFR 312.2 means:

  • 21 = Title 21
  • CFR = Code of Federal Regulations
  • 312.12 (312 = part and 2 = section)

There is a helpful website that you can use to quickly find and research the regulations. As an educator in our industry and as a member of academia, I strongly suggest that you read the regulations that pertain to your roles (and your specific area) even if you have read them before. It is important to stay current!

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Did you know that a new FDA draft proposal threatens to "get strict" with clinical investigators? The proposal suggests a rule that would disqualify a life science clinical investigator (e.g, a clinical investigator working in the field of biologics) from working on clinical investigations associated with other life science fields such as pharmaceuticals or medical devices.
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