(1997; 248 pages) [French]
5. Sampling during pharmaceutical inspections
Pharmaceutical inspectors may be called upon to take samples from retail or hospital pharmacies or from industry and wholesalers, either on a routine basis or in a variety of special circumstances, such as:
- following the discovery of products that show signs of possible deterioration, contamination or adulteration;
- when a particular product is suspected of being either ineffective or responsible for adverse clinical reactions;
- when preparations are compounded on the premises.1
1 For an individually compounded medicine prepared on a physician’s prescription, the whole container with its contents is usually taken.
For deteriorated dosage forms, the sample should consist of one or several retail containers of the product that shows visual signs of deterioration.
When a complaint has been received about a drug product, the sample should include the original container and, if possible, one or more containers with their content of the same product bearing the same batch number.