GxP Lifeline Pharmaceutical Publication Click to visit GxP Lifeline Home Click to visit mastercontrol.com

Featured Articles

November 2011

John Avellanet

Reading the FDA Tea Leaves                   

by John Avellanet
Management Director, Cerulean Associates, LLC

Publisher Henry Luce once wrote, "Business, more than any other occupation, is a continual dealing with the future; it is a continual calculation, an instinctive exercise in foresight." When business mixes with regulation, foresight will, and must, be influenced by the anticipation of regulatory action.

As the 21st century continues to drive itself forward, it is becoming clear that the US Food and Drug Administration (FDA) is striving to meet modern challenges. Of especial relevance to executives in industries regulated by the FDA is the immediate impact—for the foreseeable future—of the trends shaping agency action. These actions may include the issuance of guidance documents, inspectional strategies and medicinal product approvals/disapprovals. When considering these potential actions, the business executive has a simple question: Will I, my firm, or our products get caught in the crossfires of change without being prepared?

Read more

Annex 11 and 21 CFR Part 11: Comparisons for International Compliance

by Orlando Lopez
Independent Consultant

The two (2) essential resources available to regulated life-science professionals regarding the validation of computer systems are: the United State's Food and Drug Administration's (US FDA) rule on Electronic Records/Signatures (21 CFR Part 11 a.k.a. Part 11) and the EMEA's Guidelines to Good Manufacturing Practice (GMP) - Annex 11, Computerized Systems (a.k.a. EU Annex 11).

Part 11 establishes the requirements for the technical and procedural controls that must be met by the regulated user if the regulated user chooses to maintain regulated records electronically. Part 11 was published in March 1997. It is strictly applicable in the US to all FDA program areas. Part 11 is applicable also to manufacturers outside of the US and its territories who wish to gain US FDA market approval. Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations. For the purpose of this analysis it is required to consider the Part 11 Guideline (2003). This guidance is the one used by the FDA for interpretation and to enforce the Part 11 requirements established in the Part 11 regulation. (See Analysis of Part 11).

Read more


Featured Webinar:

Featured Service:

Previous Newsletters:

Watch Customer Videos

View Upcoming Events

Did You Know?

Quality Management Workshops
February 15-16, 2012, Allschwil, Switzerland

View More Events

"It seems a rather uncontroversial proposition: FDA-regulated companies are responsible for their vendors, including every contracted piece of work that is done on the company’s behalf. If problems develop, it makes no difference whether a company did it…or a contractor did it for them. Two seemingly unrelated items this week suggest that FDA is becoming concerned about whether FDA-regulated companies are overseeing their vendors."
Read More