Annex 5 WHO good distribution practices for pharmaceutical products

that the products are properly handled and secure at all times. The shipmentcontainer should enable identification of the container’s contents and source.11.3 The need for any special transport and/or storage conditions shouldbe stated on the shipment container label. If a pharmaceutical product isintended for transfer to areas outside the control of the manufacturer’sproducts management system, the name and address of the manufacturer,special transport conditions and any special legal requirements, includingsafety symbols, should also be included on the container label.11.4 Normally, internationally and/or nationally accepted abbreviations,names or codes should be used in the labelling of shipment containers.11.5 Special care should be taken when using dry ice in shipmentcontainers. In addition to safety issues it must be ensured that thepharmaceutical product does not come into contact with the dry ice, as itmay have an adverse effect on the quality of the product.11.6 Written procedures should be available for the handling of damagedand/or broken shipment containers. Particular attention should be paid tothose containing potentially toxic and hazardous products.12. Dispatch and receipt12.1 Pharmaceutical products should only be sold and/or distributed topersons or entities that are authorized to acquire such products in accordancewith the applicable national, regional and international legislation. Writtenproof of such authority must be obtained prior to the distribution of productsto such persons or entities.12.2 Prior to the dispatch of the pharmaceutical products, the suppliershould ensure that the person or entity, e.g. the contract acceptor fortransportation of the pharmaceutical products, is aware of the pharmaceuticalproducts to be distributed and complies with the appropriate storage andtransport conditions.12.3 The dispatch and transportation of pharmaceutical products shouldbe undertaken only after the receipt of a valid delivery order or materialreplenishment plan, which should be documented.12.4 Written procedures for the dispatch of pharmaceutical productsshould be established. Such procedures should take into account thenature of the product as well as any special precautions to be observed.Pharmaceutical products under quarantine will require release for dispatchby the person responsible for quality (see 6.3).12.5 Records for the dispatch of pharmaceutical products should beprepared and should include at least the following information:253