(1997; 248 pages) [French]
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.