Quality & Compliance: Regulatory Forces Shaping Biopharmaceutical QA/QC in 2010

Posted 01 June 2010 | By

Over the last 10 years, I have presented my impressions of the impact of changing regulatory forces on biopharmaceutical quality assurance/quality control (QA/QC) in the 21st century.1,2 Today, changing regulatory forces at both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) continue to shape biopharmaceutical QA/QC in the following three ways:


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