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
2.3 Incoming samples

As an initial step in quality evaluation, each incoming sample and the accompanying documents should be numbered and logged in a central register, which may be a record book, a card file, or data processing equipment. The entry should indicate the date when the sample was received and the lead unit to which it was forwarded. To facilitate the routing and tracing of samples, a list of the lead units assigned to each drug on the market should be kept in the central registry. Any unlisted products can then be assigned on a case-to-case basis by the head of the laboratory.

All persons, and particularly pharmaceutical inspectors, who frequently submit samples should be provided with standard “test request” forms and such a form should accompany each sample submitted to the laboratory. It should provide the following information:

- the name of the institution or inspector that supplied the sample;

- the source of the material;

- a full description of the product, including its composition, brand name, dosage form, concentration or strength, manufacturer, and batch number (if available);

- the size of the sample, and the reason for requesting the analysis.

Other information that is often needed includes the date on which the sample was collected, the size of the consignment from which it was taken, the expiry date, and the pharmacopoeial specification to be used for testing.

When the sample is first received it should be immediately inspected to ensure that the labelling is in conformity with the information contained in the test request. If discrepancies are found, or if the sample is obviously damaged, the fact should be recorded at once on the test request form.

No sample should be examined until the relevant test request has been received. If this is lacking, the sample should be safely stored until all the relevant documentation has been received. In emergencies a request for analysis may be accepted verbally. In this event all details should immediately be placed on record pending the receipt of written confirmation.

Incoming samples and test requests should be numbered consecutively. For each sample a self-adhesive label bearing this registration number should be affixed to the container in such a way as not to obliterate other markings or inscriptions. If a request refers to two or more drugs, to different dosage forms, or to different batches of the same drug, separate registration numbers should be assigned to each. Photocopies of all documentation should accompany each numbered sample when it is forwarded to the lead unit.

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