Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
(1997; 248 pages) [French] View the PDF document
Table of Contents
Open this folder and view contentsIntroduction
Open this folder and view contents1. National drug regulation
Open this folder and view contents2. Product assessment and registration
Close this folder3. Distribution
Close this folderQuality assurance in pharmaceutical supply systems1
View the document1. Introduction and general considerations
Open this folder and view contents2. Elements of quality assessment and assurance
Open this folder and view contents3. Pre-marketing quality assessment
Close this folder4. Drug quality surveillance during marketing
View the document4.1 Quality surveillance during manufacture
View the document4.2 Quality surveillance of imported drugs
View the document4.3 Quality surveillance during distribution
View the documentReferences
Open this folder and view contents4. The international pharmacopoeia and related activities
Open this folder and view contents5. Basic tests
Open this folder and view contents6. Laboratory services
Open this folder and view contents7. International trade in pharmaceuticals
Open this folder and view contents8. Counterfeit products
Open this folder and view contents9. Training
View the documentSelected WHO publications of related interest
View the documentBack cover
4.3 Quality surveillance during distribution

In the process of quality surveillance during distribution particular attention should be paid to personnel qualifications, storage facilities and transport conditions.

Every pharmaceutical product has a shelf-life during which its quality may be expected to remain within acceptable limits, but which may be seriously shortened by improper storage conditions. There is therefore a need to ensure - especially in adverse climatic conditions - that during all phases of distribution adequate conditions of storage are maintained.

For drugs that are known to have a short shelf-life, the expiry date should be stated clearly (no code being used) on all drug labels. The inclusion of expiry dates on the labelling provides a uniform system of indicating shelf-life under specified conditions of storage. In addition, the indication of the date of manufacture would further facilitate the quality surveillance of pharmaceutical products during distribution.

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