Process Validation in the light of the revised Annex 15 and FDA Requirements

Process Validation in the light of the revised Annex 15 and FDA Requirements

Berlin, Germany

Course No 15734

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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


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
The focus is on process knowledge and process understanding. Both should be a result of development and verified in routine production. The “magic” 3 batches are not mentioned any more. What is very important nowadays is the term „scientific sound“, and explicit statistics are mentioned. Six Sigma elements (e.g. Design of Experiments, DoE) are also mentioned directly or indirectly. There will be a new stage in routine production called „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.


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.


FDA Thinking

  • How the concept of Process Validation is about to change
  • Ongoing changes in the Quality Management philosophy
  • Real-life examples
The current EU Approach on Process Validation
  • Process validation in EU guidelines
  • What has changed: Revision of Chapter 1 EU GMP Guide - EMA´s Guidance Process Validation - Annex 15 revision
  • The future of process validation
Background and Environment of Process Validation – Industry view
  • Process Validation in guidelines – history
  • The FDA Process Validation Guidance –an overview
  • European perspective: Annex 15 revision
Case Study Process Validation
  • 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
Basics on Statistics
  • An overview about statistical aspects
  • What statistics do you need for modern Process Validation?
Process Design
  • Quality by Design and how it is an enabler for Process Design
Systems and Tools for gaining Process Understanding and establishing the appropriate Control Strategy (I)
  • 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
Performance Qualification Approach
  • Design & qualification of facility, utilities & equipment
  • Performance qualification approach
  • Performance qualification protocol
  • Documenting the quality baseline
Continued/Ongoing Process Verification
  • 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
Workshop DoE
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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