ICG A3P Cleaning Validation
Following the application entry in the 1er October 2015 15 of the new Annex "Qualification and Validation" Good Practices for Manufacturing of health products for human and veterinary use, many of you rework the specific part of the subchapter dedicated 10 the Cleaning Validation. Indeed, this Section now has 15 subparagraphs, when the previous version dated 2001 there were only 7. This regulatory strengthening highlights major changes on this subject: Acceptance criteria based on the CRP approach, very marked distinction between manual cleaning receipts and automated ones, need for very precise rational and well argued as to choice of (these) product (s) Worst case, in the choice of areas to be sampled.
The emerging problems of this regulatory revision facing most of us many questions. Also, we thought it was appropriate that the A3P Association creates a A3P Common Interest Group on this subject. The spirit of the GIC would provide clear answers, accurate and appropriate regarding expectations' Health Authorities for the different sections of this chapter 10.
It would also be working on how we can implement the CRP approach and taking into account the differences between sites (Mother House, generics, subcontractor, animal health, skin cosmetics ... .) and therefore trying to define a general strategy for each case.The purpose of the ICG will thus develop a Cleaning Validation Master Plan for each case.
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