Annex 15 Conference

25-26 November 2015

Berlin, Germany

Course No 9379

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Speakers

Klaus Eichmüller
Regional Council Darmstadt, Germany
Gert Moelgaard
NNE Pharmaplan, Denmark
Peter Mungenast
Merck KGaA, Germany
Dr Torsten Schmidt-Bader
moveproTEC Compliance & Innovation Advisory,
Germany
Dr Thomas Schneppe
Bayer AG, Germany
Robert Schwarz
Baxalta Innovations GmbH, Austria
Dr Ingrid Walther
Pharma Consulting Walther, Germany

Objectives

The final version of the revision of Annex 15 was published End of March 2015. It will come into operation at 1 October 2015. The conference will give an overview about the new aspects of the revision regarding:

Organisation and Planning for Qualification and Validation
Validation Documentation
Qualification
Process Validation
Cleaning Validation
Transport Verification
Packaging Validation

An EU GMP inspector gives an overview about the new requirements from his point of view.

Background

Since 2001 the Annex 15 has been state of the art for Validation Master Plan, Qualification, Validation, Cleaning Validation and Change Control within the EU. 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 to be revised. The first thoughts have been provided in a concept paper. In February 2014 was a draft published and now the final version of the revision is available.

Target Group

Everyone who may be influenced by the Annex 15 revision.

Programme

ECA Annex 15 Survey
Industry view on Annex 15

Overview of the new Annex 15 revision view of an EU GMP Inspector
History of validation guidelines in the EU
The Annex 15 revision
The EMA Process Validation revision
What´s really new?

Organisation and Planning for Qualification and Validation
Integration of outsourced data in a validation
What is an “appropriate validation oversight” ?
New requirements in the Validation Master Plan
Requirements regarding the qualification of suppliers
Requirements regarding Risk Management

Validation Documentation
Good Documentation Practice – what does that mean for validation?
How to support knowledge management
Content of validation protocols and reports
Conditional approvals – a challenge

Qualification - Annex 15 revision vs FDA Process Validation Guidance
The new first step(s) URS/FDS
How to use FAT and SAT?
Combinations of qualification stages IOQ/OPQ
Interface PQ/Process Validation
Is the requirement to qualify utilities really new?
How to handle the qualification of established equipment (in-use) in the future?
What´s about alternatives (ASTM E 2500)?
Are there differences to the FDA Process Validation Guidance?

Process Validation in the new Annex 15 revision – in the light of modern
life cycle thinking
The Process Validation Life Cycle
Modern vs. traditional approach
What is a hybrid approach?
How is bracketing possible?
Are the three magic runs still applicable?
Clarification of the terms continuous process verification, continued process verification, ongoing process verification
Is the Annex 15 revision in line with the FDA Process Validation Guidance?

Cleaning validation in the new Annex 15 – how to implement the PDE concept?
Grouping of equipment – a new possibility?
How to validate manual cleaning operations`
The new acceptance criteria: PDE – how to implement?
Choice of worst case products taking account of toxicity PDE values and solubility
How to determine the cleaning validation batches?
Cleaning verification – what´s that?

Transport verification – solutions for future challenges
Requirements of Annex 15
Regulatory expectations
Qualification, Verification, Validation
Lean Verification Approach
Actual status, future challenges

Packaging Validation - from fill to finish
Requirements of Annex 15
Qualification of packaging lines
The validation of primary vs secondary packaging processes

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