Thursday 11 June 2015

Highly Potent Products – Dedicated Facilities

Malcolm Holmes has written an interesting review about changes to EU GMP called “Highly Potent Products – Dedicated Facilities.”

EU GMP Ch 5 -Changes have been made to sections 17 to 21, including adding a new section, to improve the guidance on prevention of cross-contamination and to refer to toxicological assessment to determine safe threshold values of potential cross contaminants.

To access the article, see PHSS.

Posted by Tim Sandle

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