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

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:

The stage 3 “Continued Process Verification” is a new step in validation. Also legacy process should be (re)validated regarding this life cycle. The start is stage 3 “Continued Process Verification”. The goal of the third validation stage is continual assurance that the process remains in a state of control (the validated state) during commercial manufacture. A system or systems for detecting unplanned departures from the process as designed is essential to accomplish this goal, says the Guidance. Now, also the EU requires Ongoing Process Verification as part of a validation lifecycle.

But how to implement Continued/Ongoing  Process Verification in the routine production – beginning from the definition of the control strategy to the Product Quality Review /Annual Product Review?

These questions are discussed, and the possibilities for implementation are covered.

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 since 1 October 2015,  also a Continued Process Verification, called Ongoing Process Verification, is mentioned.