ANALYSIS OF FDA AND EU GMP ENFORCEMENT ACTIVITY shows inadequate investigation of manufacturing and product nonconformances to be the most pressing concern on both sides of the Atlantic. FDA warning letters and injunctions are frequently linking GMP problems with the manufacturing of products that do not have the required new drug approval or do not meet OTC monograph standards, as the agency’s crackdown on the various types of unapproved drugs continues. In upgrading deviation investigation systems, regulators are looking for human factors analysis and a deeper understanding of the flaws in the quality system out of which the operator errors stem. FDA’s foreign warning letters reveal the growing focus on supply chain control. For biologics, the challenges of vaccine production are getting increased inspection attention as this product segment expands. FDA is concerned that Biological Product Deviation Reports are not always getting submitted on time.
VOICES FROM THE DIALOGUE:
• FDA drug GMP warning letters issued in 2008/2009 (Appendix I, pp. 25-30)
• MHRA GMP inspector Andrew Hopkins on top MHRA inspection findings(Appendix II, pp. 31-35)
• Parexel consultant David Chesney on forces impacting FDA enforcement (Appendix III, pp. 36-41)
• CDER compliance official Joe Famulare on recent GMP injunctions(Appendix IV, pp. 42-45)
CONTENTS:
2……FDA Links GMP, Drug Approval Problems
3……Advent, KV, Actavis Totowa Enjoined
8……FDA 2006 Compliance Guide Spurs Injunctions
10….Implement ICH Q8-10 and Save On Compliance
11….Warning Letters Reveal FDA Hot Buttons
12….GMPs, Application Integrity Cited At Ranbaxy
14….OOS Investigations, Records At Issue Abroad
16….75% Of Warning Letters Cite OOS Investigations
17….To Err Is Human, But Not GMP
20….Vaccine Manufacturing Draws Attention
24 Vaccine Deviation Reports Often Late
