IPQ Special Report — July/August 2009 in Review

THE PROCESS VALIDATION PARADIGM IS CHANGING and the implications for the way manufacturers control their processes and regulators inspect them are being assessed. An FDA draft guidance has made clear that validation is a journey that extends across the process lifecycle from design to qualification to continued verification, and the control dots are being connected in new ways. Regulators will be expecting a more coherent and transparent approach to assuring process and product performance and man-aging the relevant knowledge. Joined with the principles in ICH Q8-10, the FDA guidance is challenging manufacturers to remodel their control strategies and come to grips with how much they know about their processes, how they know what they know, and how they can prove to regulators that they know it. Focal points of the industry/regulator dialogue on the impact of this new life-cycle validation paradigm include legacy products, risk assessment, knowledge management, deliverables, and compliance expectations.

• FDA compliance official Grace McNally on process validation guidance (Appendix I, pp. 17-26)
• Consultant John Geigert on Stage 1 – process design (Appendix II, pp. 27-32)
• Wyeth’s Chris Smalley on Stage 2 – process qualification(Appendix III, pp. 33-39)
• Consultant Rod Thompson on Stage 3 – continued process verification (Appendix IV, pp. 40-44)


2……Not Just Test Driving Your Commercial  Process
4……Understand Variability And Document   For Later Use
6……Transitions Are Key To The Lifecycle
7……Risk Assessment, Deliverables At Issue
10….The Validation Journey Continues In   Stage 3
12….Continuous Improvement And   The Control Strategy
13….Legacy Products, Field Training Draw Attention
14….Statistics Can Be Valuable, But Not Always
15….A Rose By Any Other Name

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