The international pharmaceutical community is continuing to expand and refine its guidance for good distribution practices (GDPs) to give industry the tools it needs to protect and assess product quality in the face of the many hazards of a complex global supply chain.
Significant additions to the GDP guidance library have been forthcoming recently from WHO, USP and PDA. While there is some overlap, the guidances differ significantly in their primary areas of focus and the depth in which particular components of the GDP spectrum are addressed.
WHO’s Annex 9, “Model Guidance for the Storage and Transport of Time and Temperature Sensitive Pharmaceutical Products,” expands on its flagship GDP guidance published in 2006. Approved by the organization’s executive committee in May, the new annex represents a compilation of guidance and best practices from regulatory agencies around the world and covers a broad range of activities, with relatively detailed treatment of transport vehicles.
USP general chapter <1079> on “Good Storage and Distribution Practices for Drug Products” represents a wholesale revision from the 2003 version. The rewrite incorporates major changes to a draft sent out in early 2010 that was subsequently pulled and rewritten. The draft is out for comment until September 30.
In August, PDA released a pair of “technical reports” – TR-52 on “GDPs for the Pharmaceutical Supply Chain” and TR-53 on “Stability Testing to Support Distribution of New Drug Products.” TR-52 is more general in nature but provides an in-depth look at selection of supply chain partners, while TR-53 delineates a “stability budget” concept for ensuring appropriate shipment and storage of temperature-sensitive products. [Editor’s note: For a review of PDA initiatives in the distribution and cold chain areas, see IPQ “In the News” May 6, 2011].
[An analysis and comparison of these new GDP documents and a look at the range of CMC/GMP guidances emerging through the WHO pipeline is provided for subscribers here. Non-subscribers can purchase the full article for $195 by contacting Jonathan Trethowan (Jonathan@ipq.org). For subscription/license information, click here].
See IPQ’s recent GDP-related stories:
New EU Draft Guideline Clarifies, Broadens and Deepens Expectations for GDPs
Multifaceted Falsified Medicines Directive Cleared in Europe; Implementation Will Pose Challenges for Industry and Regulators
Regulatory Focus on Good Distribution Practices Intensifying Across the Globe
Differences in National Shipping Requirements Challenge International Pharma
“Stability Budget” to Assure Quality During Drug Distribution Proposed by PDA Task Force with ICH Adoption in Mind
Complying With Serialization Mandates Requires Long Lead Times, Experts Warn
GS1 Global Standards Gaining Traction as Drug Serialization Deadlines Loom
More Guidance on Transport Storage Conditions Targeted by EMA
Temperature and Storage Conditions Top the List of Major/Critical Deficiencies in MHRA GDP Inspections
EMA Issues Q&A on Supply Chain Traceability to Support Revised Medicinal Gas Annex