The new FDA/EU Approach to Process Validation

The new FDA/EU Approach to Process Validation

Hamburg, Germany

Course No 9184


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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 the new 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:

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 new EU campaign of the revision of the EU GMP Guide also modern process aspects are under discussion.

How can the new requirements be achieved?
How fit the new FDA requirements into European guidelines?
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 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 as 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“. Since January 2013 the revision of chapter 1 of the EU GMP Guide is also valid. This chapter gives hints for more emphasises on process capabilities and varieties within process validation also in Europe. EMA´s new Process Validation Draft Guidance mention also an Enhanced Approach and a Processs Life Cycle for Process Validation. Otherwise the traditional approach is still acceptable.

Since February 2014, a new draft revision of EU GMP Annex 15 on “Qualification and Validation” is available from the EU Commission. There are some significant changes and many similarities to the US FDA Process Validation Guideline. The course will introduce the new document and compare the EU and FDA approaches.

Also in February 2014, EMA´s new Process Validation Guideline and is in operation since August 2014.

Note: The number of participants is limited to 36 persons.

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´s New Thinking
How the concept of Process Validation is about to change
Ongoing changes in the Quality Management philosophy
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 new Guidance Process Validation
Annex 15 draft revision
The future of process validation

Background and Environment of Process Validation – Industry view
Process Validation in guidelines – history
The new FDA Process Validation Guidance – an overview
European perspective
Annex 15 draft revision

SOP outline for 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
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 synthesis

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

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 calculation

PPQ Workshop
The delegates make a statistical evaluation of validation data (e.g. trend analysis, Cpk).

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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