WHO TRS (Technical Report Series) 1010, 2018 Annex 3


WHO TRS (Technical Report Series) 1010, 2018 Annex 3

Considerations for requesting analysis of medicines samples

An earlier version of this guidance was published as Considerations for requesting 
analysis of drug samples in 2002.

Medicines quality control testing independent of manufacturers is an important tool of medicines regulation. However, it demands considerable resources and the need for analysis should therefore always be thoroughly considered. Independent quality control testing should be performed if it adds value to the evaluation performed, when viewed from a public health perspective, and it should not cause unnecessary delays in access to medicines.

Testing should focus on medicines most likely to pose a risk to patients, for example, medicines:

■ produced by manufacturers for which poor evidence of compliance with the principles of good manufacturing practices (GMP) (1) is available, or where the origin is uncertain;

■ suspected of being falsified;

■ suspected of being substandard because of incorrect distribution or storage conditions, or their instability;

■ suspected of causing adverse reactions due to a quality defect;

■ for which analytical testing results are needed as evidence in litigation (requires the implementation of a rigorous chain of custody – see World Health Organization (WHO) guidelines) (2).

The risk of poor quality should be assessed before deciding to request analysis of a particular product. For example, if the manufacturing site has been found to comply with GMP principles, the manufacturer is under regular supervision of an authority applying international standards, and there is no specific reason for testing of the product (such as a quality complaint or a suspicion of quality deterioration during distribution or storage), the manufacturer’s batch certificate may be relied upon to indicate the quality of the product. Such a certificate should be issued in accordance with the criteria applicable to the WHO Model Certificate of good manufacturing practices (3) or WHO Certification Scheme (4).

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WHO TRS (Technical Report Series) 1010, 2018 Annex 3:

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