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
Close this folder2. Use of terms
View the document2.1 Sampling operations
View the document2.2 Samples
View the document2.3 Quantities of material
View the document2.4 Personnel
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
 
2.2 Samples

Sample: a portion of a material collected according to a defined sampling procedure. The size of any sample should be sufficient to carry out all anticipated test procedures, including all repetitions. If the quantity of material available is not sufficient for the intended analyses and for the retention samples, the inspector must record that the sampled material is the available sample (see below) and the evaluation of the results must take account of the limitations deriving from the insufficient sample size.

Samples should be stored in accordance with storage instructions for the respective drug; closures and labels should be of such a kind that unauthorized opening can be detected.

Available sample: whatever total quantity of sample material is available.

Final sample: sample ready for the application of the test procedure.

Original sample: sample collected directly from the material.

Pooled sample: sample resulting from the pooling of all or parts of two or more samples of the material.

Random sample: sample in which the different fractions of the material have equal probability of being represented.

Representative sample: sample obtained according to a sampling procedure designed to ensure that the different properties of a nonuniform material are proportionately represented.

Retention sample: sample collected and reserved for future controls. The size of a retention sample should be sufficient to allow at least two confirmatory analyses. In some cases statutory regulations may require one or more retention samples, each of which must be separately packaged and sealed.

Selected sample: sample obtained according to a sampling procedure designed to select a fraction of the material that is likely to have special properties. A selected sample that is likely to contain deteriorated, contaminated, adulterated or otherwise unacceptable material is known as an extreme sample.

to previous section
to next section
 
 
The WHO Essential Medicines and Health Products Information Portal was designed and is maintained by Human Info NGO. Last updated: October 7, 2014