youtor.org
>> YOUR LINK HERE: ___ http://youtube.com/watch?v=AvtpJMBSajs
Links • • FDA CDER Drug Landing Page: https://www.fda.gov/drugs • • FDA Drug current Good Manufacturing Practice (CGMP) Regulations: https://www.fda.gov/drugs/pharmaceuti... • • 21 CFR § 210: https://www.accessdata.fda.gov/script... • • 21 CFR § 210.1: https://www.accessdata.fda.gov/script... • • EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines: https://health.ec.europa.eu/medicinal... • • EU Pharmaceutical GMPs: https://www.ema.europa.eu/en/human-re... • Requirement name and location • Our topic, Status of current good manufacturing practice regulations, coming directly from 21 CFR § 210.1. • Outsourced Processes in 5 words: • Define Framework for Drug Regulations
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