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Labcompliance News, August 2007

August 20, 2007

New Interactive Video Seminars for Cost Effective FDA/EU Compliance

Now Labcompliance offers Video Seminars on CD's in addition to the popular audio seminar series. Currently five seminars are available. topics include FDA's new 21 CFR Part 11, OOS, Method Validation, Laboratory Inspections and Good Laboratory Practice Regulations. For content details, the seminar format and ordering, click here.

August 22, 2007

USP Chapter <1226> to be Released in December 2007

The new USP General Chapter "Verification of Compendial Methods" will be published in the second supplement to USP 30 - NF 25 (2007), According to the new chapter compendial methods don't need to be fully validated but the suitability of the method should be demonstrated. The goal of the chapters are

  • Help to clarify on how to verify the suitability of compendial methods
  • Provide consistency between laboratories and regulatory agencies
  • Present a high level view of the verification process
  • Provide guidelines on how to apply performance characteristics while allowing free flexibility to determine which performance characteristics are most appropriate

Unfortunately the final version is not as detailed a earlier draft versions. More details such as SOPs and a checklists have also been provided in a recent audio seminar from Labcompliance. Horacio Pappa of the USP has also presented two tables with examples for implementing the chapter in a conference presentation. This presentation is also included in the reference material of the audio seminar. 

August 22, 2007

Updated Contact List at FDA CDER   

The USFDA Center for Drug Evaluation and Research (CDER) has updated its directory with key officials. The 24 page list includes names, functions and phone numbers. This is a good way to get in direct contact with FDA officials.

August 22, 2007 

New FDA Process Validation Guidance Under Development

The FDA is working on a new guide for process validation. The guide is expected to be published as a draft and will replace the existing guidance that has been available since 1987. Grace E. McNally of FDA's CDER Office of Compliance, Division of Manufacturing & Product Quality, gave a presentation on FDA's past, current and future view for process validation at the 31st International GMP Conference in Athens, Georgia. Grace McNally started the presentation with limitations of the current approach which discourages ful process understanding and which makes root cause analysis more difficult because process not well understood. Next, McNally elaborated in detail of the lifecycle approach for process validation with the four major steps: design, confirm, monitor, assess. She emphasized that that overall validation is not “completed” but ongoing. The presentation can be downloaded from the Labcompliance Usersclub. For information and ordering, click here.