Seminar Nr. 15910
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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:
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.
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.
The addressees of the event are qualified staff charged with or responsible for validation activities, especially regarding stage 3 (Continued/Ongoing Process Verification) of the process validation life cycle. We mean commissioners for validation, heads of quality assurance, department heads, etc. It also addresses members of validation teams (e.g. chemists, pharmacists, microbiologists) as well as staff who is involved in process monitoring activities and consultants.
Overview: The new process validation guides from FDA and EMA and the new industry guides from ISPE, PDA and ECA: content and principles