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.
Posted by Tim Sandle
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