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
Open this folder and view contents3. Distribution
Open this folder and view contents4. The international pharmacopoeia and related activities
Open this folder and view contents5. Basic tests
Close this folder6. Laboratory services
Open this folder and view contentsNational laboratories for drug quality surveillance and control1
Close this folderGood laboratory practices in governmental drug control laboratories1
View the document1. General
Close this folder2. Management and operational issues
View the document2.1 Organizational structure
View the document2.2 Staffing
View the document2.3 Incoming samples
View the document2.4 Analytical worksheet
View the document2.5 Testing
View the document2.6 Evaluation of test results
View the document2.7 Retention samples
View the document2.8 Specifications repertory
View the document2.9 Reagents
View the document2.10 Reference materials
View the document2.11 Instruments and their calibration
View the document2.12 Safety in drug control laboratories
View the documentReferences
Open this folder and view contentsSampling procedure for industrially manufactured pharmaceuticals1
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
2.7 Retention samples

A retention sample originating from the same consignment as the analytical sample must always be kept in the laboratory - when possible in the original container - for use if the results of the analysis are disputed. This is usually prepared by the lead unit from the sample as received. The sample should therefore be large enough to provide an adequate reserve even when a number of replicate tests are required.

Sometimes, however, the retention sample is prepared by the sampling inspector when the analytical sample is taken. In this case the two samples should be separately packaged and transferred together to the laboratory. The retention sample is then labelled as such and given a registration number before it is forwarded with the analytical sample for storage in the lead unit.

Once all the required tests have been performed, any remaining portions of the sample should be resealed in their original containers. They should then be labelled with the date on which they may be discarded and placed in a locked cabinet in central store, if necessary at low temperature. Samples found to comply with specification should be kept for at least 6 months. Those that do not should be kept for at least one year, or for any longer period specified in current regulations.

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