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
2.6 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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