Speakers
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
Objectives
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
Background
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.
Programme
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
- 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
- Annex 15´s 8-stage Qualification
- ASTM 2500 as an alternative
- Case Study Qualification regarding ASTM 2500
- ICH Q 8
- Continuous Process Verification
- Case Study: Design Space, PAT Application, Design Space Verification, Process Governance during DP lifecycle
- Ongoing Process Verification vs. Continued Process Verification
- Case Study
- Outlook
- Qualification, Validation, Verification
- Requirements of Annex 15
- Guideline Good Transportation Practice
- Case Study
- Requirements of Annex 15
- Qualification of packaging lines
- The valiation of primary vs secondary packaging processes
- Case Study
- Requirements of Annex 15
- EMA guidance on PDE: PDE and ADE similarities and difference, Setting cleaning limit – risk assessment approach
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