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
 
2.3 Quantities of material

Batch: “a quantity of any drug produced during a given cycle of manufacture.”1

1 As defined in Good Practices in the Manufacture and Quality Control of Drugs (WHO Official Records, No. 226, 1975, p. 88).

If the manufacturing process is continuous, the batch originates in a defined period of time during which the manufacturing conditions have not been modified.

Consignment: quantity of a bulk starting material, or of a drug product, made by one manufacturer that is supplied at one time in response to a particular request or order. A consignment may comprise one or more packages or containers and may include material belonging to more than one batch.

Sampling unit: discrete part of a consignment, such as an individual package, drum or container.

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