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Annex 5 WHO good distribution practices for pharmaceutical products

Annex 5 WHO good distribution practices for pharmaceutical products

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— date of dispatch;— complete business name and address (no acronyms), type of entityresponsible <strong>for</strong> the transportation, telephone number and names ofcontact persons;— complete business name, address (no acronyms), and status of theaddressee (e.g. retail pharmacy, hospital or community clinic);— a description of the <strong>products</strong> including, e.g. name, dosage <strong>for</strong>m andstrength (if applicable);— quantity of the <strong>products</strong>, i.e. number of containers and quantity percontainer (if applicable);— applicable transport and storage conditions;— a unique number to allow identification of the delivery order; and— assigned batch number and expiry date (where not possible at dispatch,this in<strong>for</strong>mation should at least be kept at receipt to facilitate traceability).12.6 Records of dispatch should contain enough in<strong>for</strong>mation to enabletraceability of the <strong>pharmaceutical</strong> product. Such records should facilitatethe recall of a batch of a product, if necessary, as well as the investigation ofcounterfeit or potentially counterfeit <strong>pharmaceutical</strong> <strong>products</strong>.12.7 In addition, the assigned batch number and expiry date of<strong>pharmaceutical</strong> <strong>products</strong> should be recorded at the point of receipt tofacilitate traceability.12.8 Methods of transportation, including vehicles to be used, should beselected with care, and local conditions should be considered, includingthe climate and any seasonal variations experienced. Delivery of <strong>products</strong>requiring controlled temperatures should be in accordance with theapplicable storage and transport conditions.12.9 Delivery schedules should be established and routes planned, takinglocal needs and conditions into account. Such schedules and plans shouldbe realistic and systematic. Security risks should also be taken into accountwhen planning the schedules and routes of the delivery.12.10 Care should be taken to ensure that the volume of <strong>pharmaceutical</strong><strong>products</strong> ordered does not exceed the capacity of storage facilities at thedestination.12.11 Vehicles and containers should be loaded carefully and systematically,where applicable on a first-out/last-in basis, to save time when unloading,prevent physical damage and reduce security risks. Extra care should betaken during loading and unloading of cartons to avoid damage.12.12 Pharmaceutical <strong>products</strong> should not be supplied or received aftertheir expiry date, or so close to the expiry date that this date is likely to bereached be<strong>for</strong>e the <strong>products</strong> are used by the consumer.254

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