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Reflection paper on microbiological aspects
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Guideline on specifications: test procedures and ...
www.ema.europa.eu82 ‘Reflection paper on markers used for quantitative and qualitative analysis of HMPs/THMPs’ 83 (EMEA/HMPC/253629/2007) as outlined in the Concept paper EMA/HMPC/217753/2015. Particular 84 attention has been paid to adjustment with the in …