Process Validation in the light of the revised Annex 15 and FDA Requirements ***Booked up - additional date 15-16 October 2015***

Process Validation in the light of the revised Annex 15 and FDA Requirements ***Booked up - additional date 15-16 October 2015***

Berlin, Germany

Seminar Nr. 9185


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Dr Christopher Burgess, Burgess Analytical Consultancy, UK
Klaus Eichmüller, Regional Council Darmstadt, GMP Inspectorate, Germany
Gert Moelgaard, NNE Pharmaplan, Denmark
Dr Thomas Schneppe, Bayer Pharma 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
Real-life examples

The new EU Approach on Process Validation
Process validation in EU guidelines
What is new?
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

Process Design
Validation as a lifecycle concept
Development prerequisites
Criticality of Process Design
Process definition and design space

Design of Experiments – Principles of Defining the
Design Space
Why bother to design experiments?
DoE versus one factor at a time
Types of design
Basics of a simple 2x2 factorial design
Tutorial example of application to a chemical

Design of Experiments –
Application examples of factorial design
Principles and practice of full 3 factor 2 level design
Tutorial example of application to a analytical method robustness study
Supporting Excel spreadsheet.
Tutorial example of application of a reduced design to a excipient formulation study

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

Tutorial Workshop DoE
All delegates receive an Excel spreadsheet with the equations and detailed calculations.

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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