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

4. Packaging and labelling of samples

The container used to store a sample should not interact with the sampled material nor allow contamination. It should also protect the sample from light, air, moisture, etc., as required by the storage directions for the material sampled. As a general rule, the container should be sealed and tamperproof. The container must be properly labelled.

Samples of loose materials, whether solid or liquid, should be placed in one or more clean containers. Liquid samples should be transported in glass bottles closed by screw-tops with inert liners that provide a good vapour-proof (moisture-proof) seal for the contents. Glass screw-top jars are preferable also for solid or semi-solid materials, but metal tins may be used when there is no risk of chemical interaction. In this case the lids should be taped shut. The use of plastic containers is not recommended. Light-sensitive materials should be protected by using amber glass containers or by wrapping colourless glass containers in black paper.

Solid dosage forms, such as tablets or granules, should be protected during transit, either by totally filling the container with the product or by filling any residual space with a suitable material. All containers should be sealed and labelled and all samples from an individual sampling unit of a single consignment should be transported in a single sealed box that is adequately packaged to avoid breakage in transport.

All containers that come apart (e.g. screw-capped jars, metal tins with separate lids) should be labelled on all parts to avoid cross-contamination when they are opened for examination.

If one sample is divided into several sample containers, they should be transported in a single, sealed box, labelled to identify the product, the consignment from which the sample was drawn, the size of the sample, the date and the place of sampling, and the name of the inspector. If the sample is collected in one container only, which is already provided with a tamperproof seal, the label with the necessary information may be attached directly to the container.

Security and adequate storage conditions must be ensured for the rooms where samples are stored.

Supervision of the sampling process should also be provided.

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