SQA Regulatory Surveillance Summary 4 | Monthly Update 2021
SQA
JUNE 10, 2021
Commission in March 2015 after the publication, in December 2014, of the Q3D Guideline on Elemental Impurities (EI) by the International Council for Harmonization (ICH). FDA plant inspection and pay $50 million in fines and forfeiture. Guidance on the Licensing of Biosimilar Products, 06 May 2021.
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