Status of cGMP regulations Part 210.1 - (Pharma Executive Series #02)

Описание к видео Status of cGMP regulations Part 210.1 - (Pharma Executive Series #02)

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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