ECA Contamination Control Strategy Guide updated

Recommendation

6/7 February 2024

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Industry is still waiting for the new Annex 1 of the EU GMP Guideline - and there is still speculation about the implementation time after publication. The latest information available is that a final version is probably with the responsible bodies of the European Commission for signature.

But that does not stop industry from preparing for publication. You could already read about the new requirement for a strategy for contamination control measures defined in the revised Annex 1. To provide assistance in preparing and documenting such a strategy, the specifically set up ECA Contamination Control Strategy Expert Task Force developed

• a guideline, 
• a template,  
• an example of a GAP analysis and  
• an overview of helpful documents and official guidelines

and made it all available to all interested parties free of charge.

Based on the information currently available on Annex 1 and on some suggestions and comments received after the publication of the first version of the Contamination Control Strategy Guide, Attachment 3 of this guidance document has now been revised to make it clearer and easier to understand in some places.

The most important updates of the CCS Guide Attachment 3

Attachment 3 comprises the "Template for the Contamination Control Strategy Document (example)". The following points have been changed:

• 0.2 New: It is recommended that the CCS document be approved and reviewed and updated on an ongoing basis. If appropriate, the document could be included in the Site Master File. For a facility under construction or a major facility renovation or development, consideration should be given to the usefulness of including the CCS in the project documentation. 
• 1.1 The Processes: Update of the list of possible adequate contents 
• 1.2 1 General: Update of the list of possible subjects 
• 11 Process Validation: The note on Cleaning Validation has been moved to chapter 
• 13 Cleaning and Disinfection - Explanation updated 
• 14.2.1 Environment: The explanation has been supplemented and made clearer. 
• 16 Continuous improvement based on information derived from the above: The explanation was updated and supplemented.

If further versions of Annex 1 or the final document are published, updates will of course follow.

Further information and the download of the guide can also be found on the ECA Foundation website.