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Monthly Archives: February 2020

ICH Q12 is here. What Does it Mean for Pharma?

The International Council for Harmonisation (ICH) is an organization which brings together the pharmaceutical industry and regulatory authorities to improve the synchronization of industry regulations. The organization’s ultimate goal is…

Posted in APIs, ICH, Neuland Labs, Quality, regulatory | Tagged , , | Comments Off on ICH Q12 is here. What Does it Mean for Pharma?

Valsartan Contamination: A Follow-Up

Following up on our earlier post on the 2018 valsartan contamination, much has happened over the last six months. In our original post, we discussed the appearance of impurities in…

Posted in APIs, CMC, drugs, FDA, genotoxic impurities, Impurity profile, process chemistry, QA/QC, regulatory | Tagged , , , , , , | Comments Off on Valsartan Contamination: A Follow-Up