In early October, the Irish Medicines Board (IMB) published a “Guide to Control and Monitoring of Storage and Transportation Temperature Conditions for Medicinal Products and Active Substances.” The document was apparently issued in final form as comment is not requested.
The 20-page document focuses primarily on cold storage and the cold chain, but also contains sections on: ● controlled temperature storage/transportation ● mean kinetic temperature ● management of temperature excursions ● calibration of measuring devices ● written procedures and records ● training, and ● monitoring alarms and alarm checks.
Good Distribution Practices (GDPs) have been receiving heightened attention from regulators and industry association effort recently in the effort to gain better control over the increasingly complex global supply chain.
[Editor’s note: See “IPQ “In the News” Sept. 27 for recent contributions to the GDP guidance canon by WHO, USP and PDA, with links to stories on other efforts in the GDP arena around the world.]
LINKS:
[/membership]