New WHO Draft for GDP Guidance

Recommendation
14-16 May 2025
Vienna / Schwechat, Austria
Two-day training + 1-day Airport tour at Vienna Airport in cooperation with DHL
The World Health Organization WHO plans to revise its Good Storage and Distribution Practice guidelines. During the 53. WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP; October 2018), the Expert Committee recommended the consolidation of the Good Storage Practices and the Good Distribution Practices for pharmaceutical products and the elements of the Good Distribution Channel Guidance into one document. A draft for comments was posted on the WHO Medicines website under Current Projects.
In contrast to other international guidelines like those from PIC/S, the new document has not been aligned with the structure of the EU-GDP Guidelines. It comprises 21 chapters and in chapter three a comprehensive glossary. The scope is rather broad; the guideline "is intended to be applicable to all persons and outlets involved in any aspect of the storage and distribution of medical products from the premises of the manufacturer of the product to the person dispensing or providing pharmaceutical products directly to a patient or his or her agent." That includes all parties involved in trade, storage and distribution, like for example:
- Manufacturers
- Wholesalers
- Brokers and traders
- Suppliers
- Distributors
- Logistics providers, transport companies and forwarding agents
The new guidance does not necessarily call for a designated Responsible Person like EU-GDP does. However a "designated person(s) should be responsible for recalls" (chapter 10) and chapter 13 (Stock Control and Rotation) mentions a "person responsible for quality".
Related GMP News
23.04.2025MHRA Class 2 Recall due to Blister Pack Mislabeling
15.04.2025Falsified Medicinal Products: Swissmedic Intensifies Controls on International Trade
15.04.2025EMA's 3-Year Work Plan for GMDP Inspectors Working Group: What's Planned for GDP?
15.04.2025Two GDP Non-Compliance Reports published in March
15.04.2025Visit the DHL Vienna Airport Campus
15.04.2025Questions and Answers from the ECA Webinar "GDP Update 2025" - Part 1