Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
(1997; 248 pages) [French] Voir le document au format PDF
Table des matières
Ouvrir ce répertoire et afficher son contenuIntroduction
Ouvrir ce répertoire et afficher son contenu1. National drug regulation
Ouvrir ce répertoire et afficher son contenu2. Product assessment and registration
Ouvrir ce répertoire et afficher son contenu3. Distribution
Ouvrir ce répertoire et afficher son contenu4. The international pharmacopoeia and related activities
Ouvrir ce répertoire et afficher son contenu5. Basic tests
Fermer ce répertoire6. Laboratory services
Ouvrir ce répertoire et afficher son contenuNational laboratories for drug quality surveillance and control1
Fermer ce répertoireGood laboratory practices in governmental drug control laboratories1
Afficher le document1. General
Fermer ce répertoire2. Management and operational issues
Afficher le document2.1 Organizational structure
Afficher le document2.2 Staffing
Afficher le document2.3 Incoming samples
Afficher le document2.4 Analytical worksheet
Afficher le document2.5 Testing
Afficher le document2.6 Evaluation of test results
Afficher le document2.7 Retention samples
Afficher le document2.8 Specifications repertory
Afficher le document2.9 Reagents
Afficher le document2.10 Reference materials
Afficher le document2.11 Instruments and their calibration
Afficher le document2.12 Safety in drug control laboratories
Afficher le documentReferences
Ouvrir ce répertoire et afficher son contenuSampling procedure for industrially manufactured pharmaceuticals1
Ouvrir ce répertoire et afficher son contenu7. International trade in pharmaceuticals
Ouvrir ce répertoire et afficher son contenu8. Counterfeit products
Ouvrir ce répertoire et afficher son contenu9. Training
Afficher le documentSelected WHO publications of related interest
Afficher le documentBack 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.

vers la section précédente vers la section suivante
 

Dernière mise à jour: le 3 mai 2013