Modern Validation - Case Studies

Modern Validation - Case Studies

Hamburg, Germany

Course No 15521


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Dr Marc Egen, Boehringer Ingelheim, Germany

Walid El Azab, STERIS Corperation, Belgium

Timur Güvercinci, Merck Group, Germany

Peter Kralinger, Carrymed Pharma & Transport, GmbH, Austria

Dr Jean-Denis Mallet, NNE Pharmaplan, France

Gert Mølgaard, Head of ECA´s Validation Group, Denmark


The revised Annex 15 is valid since October 2015. With the revision new requirements have been implemented regarding:

  • Validation Master Plan
  • Qualification
  • Process Validation
  • Cleaning Validation
  • Transport Verification
  • Packaging Validation
In 6 Case Studies will be explained how companies implement the new Annex 15 requirements. Also the differences to the FDA Process Validation Guidance will be discussed.


Since 2001 the Annex 15 was state of the art for Validation and Qualification. In the meantime, ICH Q 8-11 has been published. The FDA has implemented most of these ICH guidelines and introduced a Validation Process Life Cycle in its Process Validation Guidance from 2011. The EMA has published a revision of its Note for Guidance on Process Validation to implement this new aspects too. This is also the reason why the Annex 15 has been revised. The Annex 15 revision is valid since October 2015.

Target Group

Everyone who may be influenced by the Annex 15 revision.


History of Validation with regard to Annex 15

  • Validation in the 70´s – focus on sterile production
  • FIP Validation Guideline
  • PIC Validation Conference 1982
  • The mother guideline of Validation: FDA´s Process Validation Guideline 1987
  • PIC/PH 1/96
  • Annex 15 2001
  • EMEA Note for Guidance on Process Validation
  • FDA Guidance CPG 7132.c08
  • WHO Process Validation Guideline
  • FDA Process Validation: Guidance for Industry
  • EMA Guideline on Process Validation
  • Annex 15 Revision
  • WHO revision of Validation Guidelines
  • EMA: Biotech Process Validation Guideline
Annex 15 vs FDA Process Validiation Guidance – Similarities and Differences
  • History of Annex 15 and FDA Process Validation Guidance
  • Role of EMA Process Validation Guideline vs. Annex 15
  • Similarities Annex 15 vs FDA Process Validation Guidance
  • Differences Annex 15 and FDA Process Validation Guidance
Lean Qualification meeting Annex 15 requirements – is this possible?
  • Annex 15´s 8-stage Qualification
  • ASTM 2500 as an alternative
  • Case Study Qualification regarding ASTM 2500
Continuous Process Verification –ICH Q8 as starting point for Process Validation
  • ICH Q 8
  • Continuous Process Verification
  • Case Study: Design Space, PAT Application, Design Space Verification, Process Governance during DP lifecycle
Ongoing Process Verification – how to get there
  • Ongoing Process Verification vs. Continued Process Verification
  • Case Study
  • Outlook
Transport Verification
  • Qualification, Validation, Verification
  • Requirements of Annex 15
  • Guideline Good Transportation Practice
  • Case Study
Packaging Validation
  • Requirements of Annex 15
  • Qualification of packaging lines
  • The valiation of primary vs secondary packaging processes
  • Case Study
Cleaning Validation
  • Requirements of Annex 15
  • EMA guidance on PDE: PDE and ADE similarities and difference, Setting cleaning limit – risk assessment approach

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