What does the catchphrase "Supply Chain Integrity" mean?

17.06.2024

Question of the Week

This term refers to the tightly sealed supply chain as it relates to the infiltration of falsified medicinal products. Keeping falsified medicinal products out of the distribution chain is the core objective of supply chain integrity.

[GMP Compliance Adviser, Chapter 16. G]

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EMA: New Q&A for Co-Processed Excipients

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The EMA has published new Questions & Answers on co-processed excipients (CoPEs) used in solid oral dosage forms, introducing a harmonised, risk-based regulatory approach applicable to human and veterinary medicines.

EMA: New Q&A on Product Lifecycle Management (PLCM)

The EMA has published new Questions & Answers on the use of the Product Lifecycle Management (PLCM) document, clarifying its role within the EU variations framework for post-approval quality changes.

What is the Data Lifecycle?

Here's the answer: