CDER will begin a human drug inspectional initiative

 

(TAMPA, FLORIDA, USA, 4 June 2010) – ISPE, a global not-for-profit association of

24,000 pharmaceutical science and manufacturing professionals, will host the US FDA’s

presentation at the ISPE Washington Conference, 7-10 June, to discuss the long

awaited next step Part 11 Inspection Assignment.  

 

As the next step of their re-examination of 21 CFR (Part 11), US FDA CDER will begin a human drug inspectional assignment against Part 11 requirements as described in the Part 11 Scope and Application guidance published in August of 2003. This effort will be part of CDER’s effort to evaluate industry’s compliance and understanding of Part 11 in light of the enforcement discretion described in the scope of application guidance. 

 

CDER intends to use the inspectional findings to help assess how to proceed with

regard to the possible modification of Part 11.  CDER intends to take appropriate action to enforce Part 11 requirements for issues raised during the inspections.

 

This presentation will be part of seminar E07 GAMP Good Practice Guide: A Risk-

Based Approach to Operation of GxP Computerized Systems, 9-10 June 2010, at the ISPE Washington Conference. The presentation will be given by George Smith, Project Manager Officer, CDER, US FDA and Sion Wyn, Consultant, Conformity, Ltd., member of core Part 11 team.

Source: web of APR