药品及相关物质取样(英文)929附录4

© World Health Organization

WHO Technical Report Series, No. 929, 2005

Annex 4

WHO guidelines for sampling of pharmaceutical products and related materials

1.Introduction61

1.1General considerations61

1.2Glossary61

1.3Purpose of sampling64

1.4Classes and types of pharmaceutical products and related

materials65

1.5Sampling facilities65

1.6Responsibilities for sampling66

1.7Health and safety67

2.Sampling process67

2.1Preparation for sampling67

2.2Sampling operation and precautions68

2.3Storage and retention69

3.Regulatory issues70

3.1Pharmaceutical inspections71

3.2Surveillance programmes71

4.Sampling on receipt (for acceptance)72

4.1Starting materials72

4.2Intermediates in the manufacturing process and bulk

pharmaceutical products73

4.3Finished products73

4.4Packaging materials (primary and secondary)74

5.Sampling plans for starting materials, packaging materials and

finished products75

5.1Starting materials76

5.2Packaging materials77

5.3Finished products78

Bibliography78 Appendix 1

Types of sampling tools80 Appendix 2

Sample collection form85 Appendix 3

Steps to be considered for inclusion in a standard operating procedure87

Examples of types of containers used to store samples of starting

materials and bulk products91 Appendix 5

Examples of use of sampling plans n, p and r93

These guidelines are primarily intended for use by governmental organizations, such as drug regulatory authorities (including inspectorates), quality control laboratories and customs and police officials, but some of the general principles may also be appro-priate for application by procurement agencies, manufacturers and customers.

These guidelines should be useful when surveying the national mar-kets for the quality of drug products in accordance with national drug quality surveillance programmes for marketed products, whether reg-istered for sale or compounded in pharmacies.

The choice of a sampling plan should always take into consideration the specific objectives of the sampling and the risks and consequences associated with inherent decision errors. The bibliography at the end of this Annex should be consulted when justifying a sampling plan for

a given purpose.

1.1General considerations

Sampling comprises the operations designed to select a portion of a pharmaceutical product (for definition, see glossary) for a defined purpose. The sampling procedure should be appropriate to the pur-pose of sampling, to the type of controls intended to be applied to the samples and to the material to be sampled. The procedure should be described in writing.

All operations related to sampling should be performed with care, using proper equipment and tools. Any contamination of the sample by dust or other foreign material is liable to jeopardize the validity of the subsequent analyses.

1.2Glossary

The definitions given below apply to the terms as used in these guide-lines. They may have different meanings in other contexts.

Available sample

Whatever total quantity of sample materials is available.

Batch

A quantity of any drug produced during a given cycle of manufacture.

If the manufacturing process is continuous, the batch originates in a defined period of time during which the manufacturing conditions are

stable and have not been modified.