(2003; 148 pages)
This guide is intended for those involved in the storage, transportation and distribution of pharmaceuticals. It is closely linked to other existing guides recommended by the WHO Expert Committee on Specifications for Pharmaceutical Preparations, such as:
• Good trade and distribution practice (GTDP) of pharmaceutical starting materials (1);
• The stability testing of pharmaceutical products containing well-established drug substances in conventional dosage forms (information given in connection with regulation for marketing authorization) (2);
• Good manufacturing practices (GMP) (3);
• The cold chain, especially for vaccines and biologicals;
• The International Pharmacopoeia (4).
The objective of this guide is to supplement the above-mentioned documents by describing the special measures considered appropriate for the storage and transportation of pharmaceuticals. However, they may be adapted to meet individual needs where necessary, provided that the desired standards of quality are still achieved.
The guidelines are applicable not only to manufacturers of medicinal products but also to pharmaceutical importers, contractors and wholesalers, and community and hospital pharmacies. They should be adjusted in line with the type of activity where the storage of pharmaceuticals is taking place. National or regional regulations should be followed for all related activities.