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
 
2.6 Evaluation of test results

The analyst should review the results as soon as possible after all the tests have been completed to determine whether they are mutually consistent and whether they meet the specification. All conclusions should be entered on the worksheet by the analyst and initialled by the supervisor.

The certificate of analysis issued by the laboratory should be based on the analytical worksheet. It should specify the sample and the registration number, state the specification to which the sample was tested, list and provide the results of all the tests that were performed and state whether or not the sample was found to comply with the requirements. Certificates stating that a sample is not in compliance with the required specification must always be signed by the head of the laboratory.

A sample may be recorded on the worksheet as conforming to specification only if it meets all the relevant requirements. Any discrepancy confirmed by replicate testing should be evaluated in relation to the results of the other tests and the conclusions reached should be discussed with the head of the laboratory before they are entered on the worksheet. This record should then be signed by each of the analysts involved.

In large laboratories responsibility for certifying samples that conform to specification usually lies with the lead unit. However, in the event of non-compliance, the head of the laboratory is ultimately responsible for recommending any regulatory action that is required.

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Última actualización: le 3 mayo 2013