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October 2010

Nancie Celini

Defining GxP Training and Learning: Part 1

  by Nancie E. 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, Manufacturing 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.

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Quality Basics Simplify Complex Engineering Document Management Challenge

  by Ted Shaar
  Freelance Writer on Quality Topics

In the spring of 2006, Ray Wilson, an internal business systems analyst for an investor-owned utility company, faced a monumental challenge: how to go about transferring the management of approximately 750,000 documents on paper, Mylar, microfiche, and other media from more than 150 different facilities to one centralized location.

He was also responsible for helping to determine which documents should be retained, creating a searchable database, and maintaining the data files that resulted from the effort.

Although the scope may have been once-in-a-lifetime, at the heart of the task was a common problem for engineers everywhere—content management for engineering drawings.

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Did you know that a newly issued final rule will affect the way that Pharmaceutical, Biologics and Contract Organizations report adverse events during clinical trials? For Pharmaceutical and Biologics companies that organize or participate in clinical trials, final rules issued by the FDA can have a significant impact on policies and procedures related to the implementation of a clinical trial. A recently issued final rule addresses how and when safety information must be reported.
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