Process Validation in the light of the revised Annex 15 and FDA Requirements
Frankfurt/Main, Germany
Course No 16359
You can find all other dates of this seminar in this overview.
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Speakers
Dr Christopher Burgess, Chair of ECA´s Analytical Quality Control Group, UK
Klaus Eichmüller, EU Inspector, Germany
Dr Line Lundsberg-Nielsen, NNE, UK
Gert Moelgaard, Past Chairman of ISPE, Head of ECA´s Validation Group, Denmark
Dr Thomas Schneppe, Bayer AG, Germany
Objectives
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:
- Process Design
- Process Qualification
- Continued Process Verification
With the revision of Annex 15 EU GMP Guide the EU is going in the same direction: Validation is a lifecycle with pharmaceutical development als basis and also a stage 3 is mentioned, called Ongoing Process Verification. In Europe 3 validation approaches are now possible – traditional, continuous and hybrid.
How can the new requirements be achieved?
How fit the FDA requirements into European guidelines and vice versa? , How can process knowledge and process understanding be demonstrated on the basis of development studies?
When is a process valid now?
Which parameters can be used for knowledge and understanding studies?
How can „continued/ongoing process verification” be realised?
How can statistics help?
These questions are discussed, and the possibilities for implementation are covered.
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 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.
Target Group
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.
Get a free of charge Inspectors Aide memoire on Process Validation
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.
Programme
FDA Thinking
- How the concept of Process Validation is about to change
- Ongoing changes in the Quality Management philosophy
- Real-life examples
- Process validation in EU guidelines
- What has changed: Revision of Chapter 1 EU GMP Guide - EMA´s Guidance Process Validation - Annex 15 revision
- Excursion QbD
- Excursion Legacy Products
- The future of process validation
- Process Validation in guidelines – history
- The FDA Process Validation Guidance –an overview
- European perspective: Annex 15 revision
- Role of SOP in the company QM System
- How to deal with the established 3 batch approach?
- Key aspects (Preconditions, Stages 1-3, Review)
- Further deliverables from the data and link to other company SOPs
- An overview about statistical aspects
- What statistics do you need for modern Process Validation?
- Quality by Design and how it is an enabler for Process Design
- Quality Risk Management
- Process Analytical Technology
- Design of Experiments (including a practical factorial design for establishing the design space or the operating ranges for the process)
- How the process design is reflected in the control strategy
- Applying control strategy for stage 2, process qualification and process validation
- Design & qualification of facility, utilities & equipment
- Performance qualification approach
- Performance qualification protocol
- Documenting the quality baseline
- Process mapping &critical process variables
- Process data collection and collation
- Trend analysis & Statistical Process Control
- Deviation management & CAPA
- Change management
- Management’s role in Process Validation
The delegates examine a process flow diagram and generate an Ishikawa diagram to identify critical elements.
PPQ Workshop
The delegates make a statistical evaluation of validation data (e.g. trend analysis, Cpk).
Continued/Ongoing Process Verification Process Verification Workshop
The delegates make a High Level Risk Assessment to analyze where they are going to focus in process verification.
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