The European Medicines Agency (EMA) is proposing to expand its guidance on transport storage conditions to better address the challenges of an increasingly complex ingredient supply and product distribution chain.
A concept paper proposing the additional transport guidance was released for comment in November. Comments are due by the end of February.
The paper builds on an earlier document, “Guideline on Declaration of Storage Conditions in the Product Information of Medicinal Products [and] for Active Substances” published in 1996 and revised in 2003. The 2003 revision dealt primarily with shipment within temperate climate zones and the use of stability studies to support product labeling.
The concept paper proposes that additional guidance is needed to reflect the shift in active substance and drug product manufacturing to “tropical zones” and/or other areas where transportation infrastructure “may be difficult” causing a “consequent increase in the complexity and vulnerability in the supply chain.”
The concept paper is divided into nine sections: ● introduction ● problem statement ● discussion ● recommendation ● proposed timetable ● resource requirements for preparation ● impact assessment ● interested parties, and ● reference to literature and guidelines.
EMA proposes that its existing guideline be revised to reflect the globalization concerns and to align it with related documents, including its GDP guidance, GMP Chapters 5, 6, 7, and Annex 18 – which are all under revision – and Annex 16. The agency also recommends creation of a new frequently-asked-questions (FAQ) document on the changes.
[More on the EMA concept paper and its proposed goals and timelines is provided for subscribers here. To subscribe to IPQ, click here.]
Recent related IPQ coverage referenced in this story:
● Active Ingredient and Starting Material Supply Chains in Focus in Draft Revision to EU GMP Guide Chapter 5
● New Draft Broadens EU GMP Guide Chapter 7 from Contracting to All Outsourced Activities
● Analytical Method Transfer In Focus in EU Effort to Revise GMP Chapter 6 on Quality Control
● Temperature and Storage Conditions Top the List of Major/Critical Deficiencies in MHRA GDP Inspections