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Labcompliance News, July 2007

July 27, 2007

New FDA Guide on Analytical Method Transfer

On April 26, 2007, the FDA a new final industry guidance entitled: Protocol for the Conduct of Method Transfer for Type C Medicated Feed Assay Methods. This guidance provides recommendations for protocols for conducting the transfer validated methods to laboratories that have no experience with the test method. The guide recommends steps for the controlled transfer and has examples for testing. It also includes an appendix with an example protocol. Although the guidance has been developed for medicated feed assay methods its concepts and recommendations are equally important for other applications. FDA's expectations for a controlled transfer of analytical methods and various options for compliance have been discussed in recent Labcompliance audio seminar that has been recorded and is available with all reference material. The guidance can be downloaded from the FDA website.

July 27, 2007

FDA Update on 21 CFR Part 11

 George Smith, Consumer Safety Officer at CDER, US FDA, and member of FDA's Part 11 task force gave an update on Part 11 at the annual meeting of GAMP America. The title of the presentation was: "Current Phase of the Part 11 Proposed Amendment Process". Main topics of the presentation have been: Problems with the original rule, examples of systems that are now outside of the scope of Part 11, current FDA concerns and approach for computer system validation, validation of COTS vs. internally developed systems and FDA's current and future approach for legacy systems. Most interesting have been examples from predicate rules that would trigger electronic audit trails and electronic signatures. Mr. Smith also informed the audience about the Part11 amendment process and he gave an outlook of Part 11 and FDA's further plans. The presentation can be downloaded from the Labcompliance UsersClub. For preview and ordering the users club, click here.

July 27, 2007

Lack of Method Transfer or Revalidation Protocol Cited in an FDA Warning Letter

The FDA expects analytical methods that are transferred between laboratories to follow a pre-approved transfer protocol. This became obvious in an FDA warning letter. The warning letter stated: "Methods that were validated at one facility and transferred to xxx site are being used without method transfer or revalidation protocol". The FDA also noted that there was no establish scientifically sound and appropriate specifications, standards, sampling plans, and test procedure designed to assure products conform to appropriate standards of identity, strength, quality, and purity. FDA's expectations for methods transfer and various options for compliance have been discussed in recent Labcompliance audio seminar that has been recorded and is available with all reference material. The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts.

July 27, 2007

FDA GMP Update

Frederick W. Blumenschein, Chief of FDA's Case Management and Guidance Branch, CDER gave an FDA GMP update at the 2nd European GMP Conference. The conference took place in Heidelberg, Germany, and was organized by the European Compliance Academy (ECA) and the University of Heidelberg. The title of the presentation was: Overview of the U.S. FDA Pharmaceutical Quality Regulatory System and Recent Surveillance, Guidance, Enforcement Activities. At the beginning Mr. Blumenschein had a lot of information on FDA's organization, on responsibilities of FDA's centers and also about FDA's inspection program. In the second part the audience was told that that the FDA will use a phased approach to modernize and harmonize GMPs. The first phase is expected to be effective at the end of this summer. Mr. Blumenschein talked about eight changes but most likely there will be more. FDA is also working on a new guide for process validation. The draft is expected to released at the end of this year. The guide will recommend a lifecycle approach to production and process control with four phases: design, confirm, assess and monitor. The presentation can be downloaded from the Labcompliance UsersClub. For preview and ordering the users club, click here.

July 27, 2007

New Review Article on Computer Validation

Led by Rory Budihandojo a team of computer validation experts authored a review article entitled: A Perspective on Computer Validation. The article provides a historical review of computer validation in the pharmaceutical industry within the last three decades, evolving from the early years' initial concept and approach to today's current practices. Also included is how the regulations and industry have progressed in addressing the topic of computer validation. Authors included Steve Coates, Ludwig Huber, Jose E. Matos, Siegfried Schmitt, David Stokes, Graham Tinsley and Maribel Rios. The article has been published by Pharmtech and as of July 2007 is available on the publishers website. Copyright rests with the publisher. For other articles from Pharmtech, click here. 

Free Document of the Month

As a 'Thank You' for our Newsletter Subscribers Labcompliance offers every month one document for free. This month's document is the SOP "Development of Requirement Specifications for Computer Systems".