Good Storage and Distribution Practice: What is the WHO GSDP Guideline about?

WHO Guideline on Good Storage and Distribution Practices for Medical Products

This document, published in April 2020, combines the hitherto separate documents on Good Distribution Practice and Good Storage Practice into one document (Technical Report Series No. 1025, Annex 7).

The guideline points out that "medical products" can be exposed to various risks in the individual phases of the supply chain, such as storage, transport and distribution, and emphasizes the need to prevent substandard or falsified products from entering the legal supply chain.

The use of the term "medical products" makes it clear that the guidelines apply not only to medicinal products but also to medical devices. However, this document does not apply to APIs and excipients.

All entities involved in the various stages of the supply chain of medical products, such as manufacturers and wholesalers as well as brokers, suppliers, distributors, logistics service providers, dealers, shipping companies, freight forwarders and, in particular, their employees, are referred to as actors in the distribution chain.

Ongoing efforts to harmonize the requirements for good distribution practice internationally are the reason that many of the requirements formulated here are similar to those in the documents discussed above.

The WHO guideline defines procedures that are intended to ensure safety within the supply chain, among other things. These include, for example:

• Authorized procurement and distribution channels with comprehensive traceability of medicines
• A quality management system for each unit involved in the distribution chain
• Qualified and trained staff
• Storage conditions with corresponding temperature monitoring, among other things
• Use of suitable transport vehicles with GPS technology (global positioning system) and engine-kill-button as well as temperature monitoring, if applicable
• Evidence that the driver is authorized to transport medical products
• Compliance with the defined transport conditions or providing a cold chain for temperature-sensitive medicines
• Documentation of these data
• Contracts covering the entire distribution chain, including subcontractors.

In order to avoid repeating what has been described so far, the requirements are not described here in detail. Further details on transport operations can be found in chapter 18 of the guideline.

In contrast to EU and FDA guidelines, the WHO guideline also contains statements on the following aspects:

• Potential risk to product quality when using dry ice and liquid nitrogen
• Specifications for systematic loading of vehicles (LIFO - last-in/first-out).
  In addition to minimizing damage and safety risks, the LIFO principle is also intended to save time during delivery.

In addition, Annex 1 of the WHO guideline contains a table with recommended limit values for storage and thus also transport temperatures (see figure 1). These limit values are based on the limit values and guidelines from pharmacopoeias.
 

Figure 1 WHO-GSDP, Annex 1 Table A7.1 Recommended limits for
descriptive storage conditions