WHO TRS (Technical Report Series) 1025, 2020 Annex 7

WHO TRS (Technical Report Series) 1025, 2020 Annex 7

Good storage and distribution practices for medical products

1. Introduction:

1.1 Storage and distribution are important activities in the supply chain management of medical products. Various people and entities may be responsible for the handling, storage and distribution of medical products. Medical products may be subjected to various risks at different stages in the supply chain, for example, purchasing, storage, repackaging, relabelling, transportation and distribution.

1.2 Substandard and falsified products are a significant threat to public health and safety. Consequently, it is essential to protect the supply chain against the penetration of such products.

1.3 This document sets out steps to assist in fulfilling the responsibilities involved in the different stages within the supply chain and to avoid the introduction of substandard and falsified products into the market. The relevant sections should be considered as particular roles that entities play in the storage and distribution of medical products.

1.4 This guideline is intended to be applicable to all entities involved in any aspect of the storage and distribution of medical products, from the premises of the manufacturer of the medical product to his or her agent, or the person dispensing or providing medical products directly to a patient. This includes all entities involved in different stages of the supply chain of medical products; manufacturers and wholesalers, as well as brokers, suppliers, distributors, logistics providers, traders, transport companies and forwarding agents and their employees.

1.5 The relevant sections of this guideline should also be considered for implementation by, amongst others, governments, regulatory bodies, international procurement organizations, donor agencies and certifying bodies, as well as all health-care workers.

1.6 This guideline can be used as a tool in the prevention of distribution of substandard and falsified products. It should, however, be noted that these are general guidelines that may be adapted to suit the prevailing situations and conditions in individual countries. National or regional guidelines may be developed to meet specific needs and situations in a particular region or country.

1.7 To maintain the quality of medical products, every party that is active in the supply chain has to comply with the applicable legislation and regulations. Every activity in the storage and distribution of medical products should be carried out according to the principles of good manufacturing practices (GMP) (1) or applicable standard such as ISO 13485 for medical devices (2); good storage practices (GSP) (3); and good distribution practices (GDP) (4), as applicable.

1.8 This guideline does not deal with dispensing to patients, as this is addressed in the Joint FIP/WHO (International Pharmaceutical Federation/World Health Organization) guidelines on good pharmacy practice (GPP) (5).

1.9 This guideline should also be read in conjunction with other WHO guidelines, for example those listed at the end of the document under References and Further reading.

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WHO TRS (Technical Report Series) 1025, 2020 Annex 7:

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