Seminar Nr. 16360
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With publication of the Guidance for Industry “Process Validation: General Principles and Practices” 2011, the FDA requires a new direction. Validation is now a „Life Cycle Process” with 3 stages:
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 to the new validation approach. In November 2008 the new “Guidance for Industry Process Validation: General Principles and Practices” was published as a draft and came into operation in January 2011. That is now FDA’s „current thinking“. Chapter 1 of the EU GMP Guide gives hints for more emphasises on process capabilities and varieties within process validation also in Europe. EMA´s Process Validation Guidance and also the revised Annex 15 which come into force on 1 October 2015 takes a life cycle approach to process validation.
The addressees of the event are qualified staff charged with or responsible for validation activities, such as commissioners for validation, heads of quality assurance, department heads, etc.
It also addresses members of validation teams (e.g. engineers, chemists, pharmacists, microbiologists) as well as representatives of the plant engineering industry and consultants.
The Guide is developed by the Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG) – English translation. This document covers the whole spectrum of process validation regarding the Annex 15 revision The Aide Memoire is really helpful as a tool to prepare for an Authority’s GMP Inspection.