Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
(1997; 248 pages) [French] Ver el documento en el formato PDF
Índice de contenido
Abrir esta carpeta y ver su contenidoIntroduction
Abrir esta carpeta y ver su contenido1. National drug regulation
Abrir esta carpeta y ver su contenido2. Product assessment and registration
Abrir esta carpeta y ver su contenido3. Distribution
Abrir esta carpeta y ver su contenido4. The international pharmacopoeia and related activities
Abrir esta carpeta y ver su contenido5. Basic tests
Cerrar esta carpeta6. Laboratory services
Abrir esta carpeta y ver su contenidoNational laboratories for drug quality surveillance and control1
Cerrar esta carpetaGood laboratory practices in governmental drug control laboratories1
Ver el documento1. General
Cerrar esta carpeta2. Management and operational issues
Ver el documento2.1 Organizational structure
Ver el documento2.2 Staffing
Ver el documento2.3 Incoming samples
Ver el documento2.4 Analytical worksheet
Ver el documento2.5 Testing
Ver el documento2.6 Evaluation of test results
Ver el documento2.7 Retention samples
Ver el documento2.8 Specifications repertory
Ver el documento2.9 Reagents
Ver el documento2.10 Reference materials
Ver el documento2.11 Instruments and their calibration
Ver el documento2.12 Safety in drug control laboratories
Ver el documentoReferences
Abrir esta carpeta y ver su contenidoSampling procedure for industrially manufactured pharmaceuticals1
Abrir esta carpeta y ver su contenido7. International trade in pharmaceuticals
Abrir esta carpeta y ver su contenido8. Counterfeit products
Abrir esta carpeta y ver su contenido9. Training
Ver el documentoSelected WHO publications of related interest
Ver el documentoBack 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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Última actualización: le 3 mayo 2013