FDA and EMA Revising GMP Regulations to Address Supply Chain Deficiencies
This article was originally published in The Gold Sheet
Executive Summary
FDA, EMA revising GMPs to establish supply chain controls. FDA looks to require identification and auditing of ingredient suppliers, heightened component security, notification of significant defects. EMA to require detailed API supply chain pedigrees and more technical agreements. QPs will have to really vouch for API sites. FDA also plans other GMP changes.
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