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EU GMP Revisions Make Formal Quality Risk Management Plans a Requirement

This article was originally published in The Gold Sheet

Executive Summary

Update on EU GMPs: risk management now required; annexes being updated.

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As Europe prepares to subject API imports to GMP controls, industry urges a different approach. Questions linger over how to keep Anti-Falsification Directive from drying up Europe’s API supplies.

FDA and EMA Revising GMP Regulations to Address Supply Chain Deficiencies

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.

FDA and EMA Revising GMP Regulations to Address Supply Chain Deficiencies

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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