Expert Task Force issues new Version of CCS Guideline
Recommendation
17/18 October 2024
Regulatory Expectations and Practical Experiences
Past February, the ECA Foundation's CCS Task Force issued the first version of a Contamination Control Strategy Guideline to assist its members in meeting this requirement according to the new Annex 1 draft. This first version was based on the second draft of the Annex 1 revision. After completion, the ECA decided to also share it publicly free of charge to support companies and facilities for which the new Annex 1 is relevant.
A first update of the Guide and Attachment 3 was provided in July. Now, with the publication of the final version of the revised Annex 1 in August, the group of authors got together again to update the CCS Guide based on the final Annex 1 version. The new version 2.0 now comprises the revision of quoted passages, the modification and insertion of individual sections and tables as well as an improved clarity. The attachments were also updated.
The ECA again offers Version 2.0 of the CCS Guideline at no costs for all colleagues in pharmaceutical industry and authorities - in line with ECA´s overall strategy not to charge for Guideline documents. To receive a copy of ECA´s Guideline "How to Develop and Document a Contamination Control Strategy" please the ECA Foundation website.
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