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
4.2 Quality surveillance of imported drugs

4.2.1 WHO Certification Scheme

The WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce (4), when used, will provide valuable data required for pharmaceutical quality assessment of imported drugs.

The scheme permits the control authorities of importing countries to obtain information on imported drugs. In this context, it is desirable to acquire knowledge of the quality and manufacturing conditions of imported drugs similar to that which could be obtained if the product were manufactured locally. The scope of the information required may vary according to the category of the drug and the control procedure adopted in the importing country.

4.2.2 Procedures at ports of entry

At the port of entry, consignments of drugs must be stored under suitable conditions, and for as short a time as possible, to prevent deterioration. If prolonged storage is to be avoided, the proper administrative procedures must be worked out and the type of information which should accompany each shipment will have to be designated. The effective involvement of pharmaceutical officers at customs would facilitate this task.

Batch control is sometimes carried out in respect of some imported drugs and considerations similar to those mentioned in section 4.1 are pertinent here.

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