Almacenamento de medicamentos

© World Health Organization WHO Technical Report Series, No. 908, 2003

Annex 9 Guide to good storage practices for pharmaceuticals1
1. 2. 3. 4. 5. 6. 7. 8.

Introduction Glossary Personnel Premises and facilities Storage requirements Returned goods Dispatch and transport Product recall

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References Bibliography Appendix Storage and labellingconditions 1.

Introduction 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 ofpharmaceutical 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);
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This guidance has been prepared in close collaboration with the International Pharmaceutical Federation (FIP).

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• The cold chain, especially for vaccines andbiologicals; • 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 areapplicable 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.
2.

Glossary The definitions given below ofsome of the terms used in this document take into account the terminology of current regulations and recommendations.
active pharmaceutical ingredient (API)

Any substance or mixture of substances intended to be used in the manufacture of a pharmaceutical dosage form and that, when used in the production of a drug, becomes an active ingredient of that drug. Such substances are intended tofurnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure and function of the body.
contamination

The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a starting material, or intermediate or finished product during production, sampling,packaging or repackaging, storage or transport.
cross-contamination

Contamination of a starting material, intermediate product or finished product with another starting material or product during production.
excipient

A substance, other than the active ingredient, which has been appropriately evaluated for safety and is included in a drug delivery system to:
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— aid in the processingof the drug delivery system during its manufacture; — protect, support or enhance stability, bioavailability, or patient acceptability; — assist in product identification; or — enhance any other attribute of the overall safety and effectiveness of the drug during storage or use.
expiry date

The date given on the individual container (usually on the label) of a drug product up to and includingwhich the product is expected to remain within specifications, if stored correctly. It is established for each batch by adding the shelf-life to the date of manufacture.
labelling

The action involving the selection of the correct label, with the required information, followed by line clearance and application of the label.
manufacture

All operations of purchase of materials and products,...