THE IMPACT OF QUALITY SYSTEM PRINCIPLES ON INSPECTION PRACTICE IS EXPANDING in depth and breadth as EU and U.S. regulators seek to evolve their GMP guidance and compliance programs in line with the new ICH Q8-10 paradigm. Reflcting Q10’s focus on the responsibilities of company management, inspectors will assess the level of management’s engagement with the quality system as a barometer of the system’s potential effectiveness. As the management focus grows, the role of the qualified person and the quality unit is being reevaluated to make sure that the regulatory expectations are viable and reflect the actual decision making power. Industry and regulators are wrestling also with how best to apply the new paradigm concepts in the API and excipient context so that requirements are clear, harmonized, fair and enforceable. Third party certification is gaining traction as a way of providing support in excipient control. Industry/regulator trust building is seen as key to realizing the quality system’s potential.
VOICES FROM THE DIALOGUE:
• Additional guidance on quality systems in ICH Q10 (pp. 3-4)
• WHO offcial Lambert on thinking globally about inspections (p. 13)
• EMEA’s Cooke on EU inspection and assessment challenges and response (pp. 15-19)
• Ongoing Revisions to EU GMP Guide and Annexes (pp. 21-22)
• Proposal for QP regulatory principles from Pfizer’sO’Sullivan (p. 25)
• CDER compliance official Famulare on GMP changes and implementing Q8-10 (pp. 33-40)
CONTENTS:
2……New ICH Quality Initiatives Underway
5……Inspection Focus Shifting To Management
6……EMEA Data Show Quality System Impact
9……EU Realigning Inspections On Risk Basis
11….UK Inspector Insider Information Offered
12….Solutions To Inspection Workload Sought
21….EMEA Revising GMP Annexes
23….Interpretation Of QP Role At Issue
26….Inconsistent EU Recall Action Cited
27….API Inspection Oversight Of Concern
28….Excipient Certification Under Discussion
31….Management Role Draws Attention In U.S.
