After the FDA moved towards a life cycle approach with its Process Validation Guidance in 2011, the EU GMP Guide now followed with the revision of Annex 15, also moving to modern process aspects (e.g. life cycle approach). But how can the industry implement the new process validation requirements? The ECA’s Good Practice Guide on Validation does provide answers.
Since the publication of FDA´s Process Validation Guidance in 2011, validation has become a life cycle approach with focus on process knowledge and process understanding based on scientific sound principles. In addition, with the revision of Annex 15 of the EU GMP Guide, the EU has also been moving to modern process aspects (e.g. life cycle approach).
The question is how to implement these new requirements – in the USA and in Europe?
To answer this question, an ECA Working Group has revised the Version 1 of ECA´s Good Practice Guide on Validation. With the revision the group wants to provide support to both regulators and industry. On one hand, the guide contains the main elements of the new approach (“what to do”). On the other hand, it also serves as a supporting guide for the implementation (“how to do”).
The revised version comprises 174 pages divided in 5 chapters and 5 annexes (with detailed analyses of the regulatory guidances).
The topics covered are e.g.:
- risk based qualification and validation
- legacy products
- case study about process validation
- case study about continued/ongoing process verification in biopharmaceutical manufacturing
The ECA Good Practice Guide on Validation will be officially launched at ECA´s Annex 15 Conference on 25/26 November 2015 in Berlin. All participants will receive a free copy of the document.
ECA´s Annex 15 Conference on 25/26 November 2015 in Berlin. All participants will receive a free copy of the document.
Course No 9379
25-26 November 2015, Berlin, Germany
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.
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
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
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