Continued/Ongoing Process Verification - How to handle part 3 of the validation life cycle

Objectives

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

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?
• 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) and Continuous Process Verification (ICH Q8) and Ongoing Process Verification (EU)?
• Are there parallels regarding Medical Devices?
• What statistic parameters could help

Background

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