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
2.1 Organizational structure

The full analysis of a drug sample involves a variety of different tests. In a small laboratory where relatively few analyses are undertaken a single analyst may have to take responsibility for carrying out all the chemical and physicochemical tests and evaluating the results. In large laboratories, on the other hand, the sample may be subdivided between several specialized subunits, each of which carries out the part of the analysis that calls for the particular skills and technology that it possesses. In every case, however, a “lead unit” or focal point must be made responsible for distributing and testing the sample and collating and interpreting the results.

The division of the laboratory into subunits may be based on the main techniques used (e.g. chemical unit, instrumental unit, microbiological unit, unit for biological safety testing) or on the type of product tested (e.g. antibiotics unit, crude drug unit, radiopharmaceuticals unit). Whichever plan is chosen, care must be taken to ensure an even distribution of the workload between units and the precise allocation of responsibilities, particularly in the designation of lead units for particular types of drugs. Units specializing in single assay techniques, such as sterility testing, pyrogen testing or special physical measurements, should be regarded as collaborating units that perform specific tests at the request of the lead unit.

Division of a laboratory into subunits should never be allowed to inhibit communication between the staff involved in testing the same sample. Intercommunication helps the lead unit to piece together all the information on which the quality of the sample is ultimately judged.

Large laboratories need various supporting and coordinating sections, including a central registry and a specifications repertory. The size of these units will depend on the number of samples received and the number of different drugs subjected to testing. The head of the central registry must be a person with wide experience in analysis and will be responsible for receiving all incoming samples and accompanying documents, supervising their delivery to the lead units and keeping a constant check on the progress of analyses and the despatch of completed reports. He or she may also be required to collate and evaluate the test results for each analysis. The specifications repertory section maintains an up-to-date collection of all quality specifications and related documents.

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