This guidance is applicable to collecting samples of drugs to be tested by the official quality control laboratory. The collection may be aimed either at assessing the quality of products on the market, in which case adequate sampling plans should apply (see, for example, "Sampling procedures for industrially manufactured pharmaceuticals" (1,2)), or at detecting substandard, spurious and counterfeit pharmaceutical products. In this case sampling shall be based on information and may involve confiscation of entire stocks to prevent further distribution. Compliance with legal procedures for sample collection, analysis and documentation is obligatory.
(a) Check that the sample is properly labelled with the following:
(i) name of sampled pharmaceutical preparation
(ii) batch number
(iii) date and source of sample; the original manufacturer's label may be helpful.
(b) Check that the records contain the following:
(i) number of samples
(ii) types of packaging and storage conditions
(iii) circumstances of sampling that may include suspected quality defects.
(c) Place seals on containers of the samples.
(d) Hand over one-third of the samples to the representative of the inspected establishment.
(e) Confirm in writing that samples were taken from the premises and have the confirmation countersigned by an appropriate official of the inspected establishment (see, for example, the sample receipt form in Appendix 4).
1. WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-first report. Geneva, World Health Organization, 1990, Annex 2 (WHO Technical Report Series, No. 790).
2. Quality assurance of pharmaceuticals. A compendium of guidelines and related materials, Vol. 1. Geneva, World Health Organization, 1997.