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

07.04.2025

LOGFILE Feature

Excerpt from the GMP Compliance Adviser, Chapter 16.H Regulatory requirements for the transport of pharmaceuticals

3 min. reading time | by Petra Rempe, PhD
Published in LOGFILE 08/2025

Do you know where your pills come from? They probably have a long journey behind them. Active ingredients from China meet excipients from India to be pressed into tablets in France, which are blister-packed in Italy and packaged in Spain before being imported to Germany – sounds unrealistic? No, because the manufacture and distribution of pharmaceuticals is a global business. Therefore it is important to speak the same language in terms of the underlying regulations. In todays feature you will read a short summary of the WHO GDSP guideline, which is not only the latest, but probably also the most globally oriented guideline on the topic of good storage and distribution.

Keep up to date with GDP by taking a closer look at chapter 16 Storage and Transportation in your GMP Compliance Adviser, the most comprehensive GMP online knowledge portal worldwide.

In its GSDP Guideline published in 2020, the WHO summarizes current requirements for the storage and transport of medical products and at the same time attempts to harmonize international requirements. This guideline also contains an annex with recommended temperature and humidity limit values for storage and therefore also transportation temperatures.

Read a short summary of the guideline below.

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.

Store at controlled room temperature	15 to 25°C
Store in a cold or cool place	8 to 15°C
Store in a refrigerator	5 ± 3°C
Store in a freezer	-20 ± 5°C
Store in deep freezer	-70 ± 10°C
Store in a dry place	No more than 60% relative humidity
Protect from moisture	No more than 60% relative humidity
Store under ambient conditions	Store in well-ventilated premises at temperatures of between 15°C and 30°C and no more than 60% relative humidity. Extraneous odours, other indications of contamination and intense light must be excluded.
Protect from light	To be maintained in the original manufacturer’s lightresistant containers
Chilled	5 ± 3°C

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

Do you have any questions or suggestions? Please contact us at: redaktion@gmp-verlag.de

Dr. Petra Rempe Written on 7 April 2025

You may also be interested in the following articles:

24.11.2025

Question of the Week

How is a QRM process initiated?

You can view the answer here:

FDA: Updated Pre-RFD Guidance for Combination Products

The U.S. FDA has released an updated final guidance on preparing a Pre-Request for Designation (Pre-RFD), replacing the previous 2018 version. The revised document provides new recommendations for interacting with the Office of Combination Products (OCP) and clarifies expectations for Pre-RFD submissions.

EDQM: 9 Virtual Training Modules on Ph. Eur. and CEPs

The EDQM has introduced a modular training programme covering chemically defined active substances and medicinal products. It will take place between 1 and 12 December 2025.

Related Products

GMP Compliance Adviser | Named User Licence | 12M

The GMP Compliance Adviser is an online publication that covers all aspects of Good Manufacturing Practice (GMP) in one source.In the GMP Compliance Adviser you’ll find: GMP in Practice This part contains 21 chapters with GMP expert knowledge to base your decisions upon. It provides practical assistance with checklists, templates and SOP examples. It is written by more than 80 authors with hands-on experience directly linked to the industry. The individual chapters describe the different aspects of GMP in clear language. Technical, organizational and procedural aspects are covered.More than 700 checklists, templates and examples of standard operation procedures taken directly out of practice help you in understanding the GMP requirements.GMP RegulationsThese chapters cover the most important GMP regulations from Europe and the United States (CFR and FDA), but also PIC/S, ICH, WHO and many more. Sample Documents In addition, the GMP Compliance Adviser contains many sample documents and practical examples that you can use.

Ready for dispatch, Delivery time appr. 2-5 workdays (2-3 weeks for christmas goodies)

€1,335.00 net excl. VAT

Details

GMP:KnowHow Pharma Logistics (GDP) | Named User License | 12M

Your knowledge base about GDP-compliant handling of your pharmaceutical logistics. It is important that you as a logistics service provider, but also as a client in the pharmaceutical industry, adhere precisely to the regulatory requirements. The GMP:KnowHow knowledge portal guides you through the regulatory jungle of the pharmaceutical and logistical supply chain! The knowledge portal gives you an easy-to-understand overview of all the important topics. Using graphics, you can easily navigate through all the areas covered by the EU GDP Guidelines (2013/C 343/01). You also have the relevant passages of the regulations directly at hand for each topic. This allows you to compare the requirements directly and saves you a lot of time on time-consuming searches and research!One thing is certain: the knowledge portal answers your questions about the supply chain of medicinal products, active pharmaceutical ingredients and medical devices. You don't have to be an expert. Yet.You will find answers to your questions in the GMP:KnowHow Pharma Logistics (GDP). Where does GDP begin, where does GMP end? What does GDP-compliant mean? When do I also have to take GMP requirements into account? What permits do I need for certain activities? What requirements do I have to fulfil? What is the current legal basis? How am I covered? What authorizations do I have for my work, e.g. from my employer? Who is responsible — the client or the contractor? And many more What is the difference to the GMP Compliance Adviser? The GMP:KnowHow Pharma Logistics (GDP) is your guideline for Good Distribution Practice. It is a product that is independent of the GMP Compliance Adviser and concentrates on content that is essential for carriers of medicinal products, active pharmaceutical ingredients and medical devices as well as for logistics clients. The focus is on practical knowledge and how to apply it in your daily business. If necessary, the relevant regulations can be called up immediately alongside the practical knowledge, and you can see the relevant paragraphs at a glance. In addition, sample documents are available to help you make immediate progress. AuthorSimone Ferrante – now Director Quality at Fisher Clinical Services – was previously Head of Quality Control and Responsible Person according to GDP (VP) for the entire Grieshaber Group. She is also a long-standing author and GDP expert at GMP-Verlag.

Ready for dispatch, Delivery time appr. 2-5 workdays (2-3 weeks for christmas goodies)

€610.00 net excl. VAT

Details

E-Learning GMP:READY | GMP for Engineers Online Course

Why are GMP rules important for technicians and engineers? Technicians and engineers play a key role in ensuring compliance with Good Manufacturing Practice (GMP) standards. They are involved in critical activities such as: planning and construction of ventilation systems, maintenance of water treatment plants, calibration of measuring sensors. Therefore, they are jointly responsible for the quality of medicines and must ensure that their work complies with GMP standards.Your advantages: Fast familiarization with GMP topics in approx. 2 hours, time- and location-independent online training, printable personal certificate, 12-month access for initial and follow-up training, automatic updates in case of legal changes, content compliant with Article 7(4) of Directive 2003/94/EC.

Ready for dispatch, Delivery time appr. 2-5 workdays (2-3 weeks for christmas goodies)

€240.00 net excl. VAT

Details

GMP Fundamentals | A Step-by-Step Guide

This handbook is a practical and easy to read guideline, giving you a quick and comprehensive overview of the complex world of Good Manufacturing Practice (GMP) without the need of previously acquired knowledge. Some topics are: GMP: Purpose and basic pharmaceutical terms Laws, licenses and inspections Personnel: Responsibility and hygiene Standard Operating Procedures (SOP) and documentation Design of rooms and facilities Processing and packaging Quality control and market release Suppliers, storage and logistics (Good Distribution Practice = GDP) Alphabetical index and abbreviations Using practical examples and comparisons to every-day life will help to easy understand GMP regulations.GMP Fundamentals is a helpful guide which facilitates the entry into the GMP world and teaches the necessary basics.

Ready for dispatch, delivery immediately after receipt of payment

€44.90 net excl. VAT

Details