EMA Annex 1 Q&A discusses bioburden considerations
European Pharmaceutical Review
FEBRUARY 6, 2024
In its answer, when considering bioburden, EMA shared that the specification limits should be “NMT 10 CFU/100ml”, in line with the guideline sterilisation-medicinal-product and active-substance ref EMA/CHMP/CVMP/QWP/850374/2015. What are the requirements for the bioburden sampling to support parametric release?
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