Modern EU and FDA Validation: Ongoing/Continued Process Verification – from the Control Strategy to Product Quality Review
Im Auftrag der ECA Academy

Zielsetzung

With the Guidance for Industry “Process Validation:
General Principles and Practices”, the FDA requires a
new direction. Validation is now a „Life Cycle Process” with 3 stages:

• Process Design
• Process Qualification
• Continued Process Verification

• What is state of the art regarding systems for detecting unplanned departures from the process?
• How to handle the monitoring at Stage 3 (Continued/Ongoing Process Verification)?
• What are the differences between Continued Process Verification (FDA), Continuous Process Verification
• (ICH Q8) and Ongoing Process Verification (EU) ?
• Are there parallels regarding Medical Devices?
• What statistic parameters could help?
• Is a statistician necessary?
• How is OPV/CPV linked to PQR/APR?
• What are the expectations of an EU Inspector?

Hintergrund

Since 1987 the FDA Guideline on Process Validation has been the basis for qualification and validation. Within the new FDA programme “Pharmaceutical cGMPs for the 21st Century” there was an announcement for a revision of the guideline. A new FDA Policy Guide of 2004 gives some hints as to the new validation approach.

In January 2011 the new “Guidance for Industry Process Validation: General Principles and Practices” was published as final guidance. That is now FDA’s „current thinking“. EMA´s new Process Validation Guidance also mentions a Life Cycle Approach for Process Validation. And with the citation of ICH Q8, the possibility to do Continuous Process Verification is also mentioned. In the new Annex 15 revision document also a Continued Process Verification, Ongoing Process Verification called, is mentioned.

In the Annex 15 revision document, valid from 1 October 2015, also a Continued Process Verification, called Ongoing Process Verification, is mentioned.