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
Open this folder and view contentsGood laboratory practices in governmental drug control laboratories1
Close this folderSampling procedure for industrially manufactured pharmaceuticals1
Open this folder and view contents1. General considerations
Open this folder and view contents2. Use of terms
View the document3. General precautions to be taken during sampling operations
View the document4. Packaging and labelling of samples
View the document5. Sampling during pharmaceutical inspections
View the document6. Sampling of pharmaceutical dosage forms in regular surveillance programmes on drug quality during marketing
View the document7. Sampling of pharmaceutical dosage forms for acceptance of consignments
Open this folder and view contents8. Sampling of starting materials
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
 

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.

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