New WHO Draft for GDP Guidance

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".

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