WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 885 - Thirty-fifth Report
(1999; 168 pages) [Spanish] View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Open this folder and view contents2. The international pharmacopoeia and related issues
Open this folder and view contents3. International Chemical Reference Substances and Infrared Reference Spectra
Open this folder and view contents4. Quality control - national laboratories
Open this folder and view contents5. Good manufacturing practices
Open this folder and view contents6. Quality systems and inspection
Open this folder and view contents7. Other quality assurance topics
Open this folder and view contents8. Nomenclature and terminology
Open this folder and view contents9. Legal aspects of pharmaceuticals
Open this folder and view contents10. Regulatory issues
Open this folder and view contents11. Training activities
View the document12. Pharmaceuticals contaminated with diethylene glycol
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1. List of available International Chemical Reference Substances1
View the documentAnnex 2. List of available International Infrared Reference Spectra1
Open this folder and view contentsAnnex 3. General guidelines for the establishment, maintenance and distribution of chemical reference substances
Open this folder and view contentsAnnex 4. Good manufacturing practices: authorized person - role, functions and training
Open this folder and view contentsAnnex 5. Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients
Close this folderAnnex 6. Guidelines for inspection of drug distribution channels
View the documentIntroductory note
View the documentGeneral considerations
View the documentGlossary
Open this folder and view contents1. Drug inspectors
Open this folder and view contents2. Inspection of establishments in the drug distribution chain
View the documentReferences
View the documentSelected further reading
View the documentAppendix 1. Checklist for inspection and the preparation of a report
View the documentAppendix 2. Guidance on sampling
View the documentAppendix 3. Guidance for inspection when pharmaceutical products are suspected to be counterfeit, spurious or substandard
View the documentAppendix 4. Sample receipt form
View the documentAnnex 7. Good pharmacy practice in community and hospital pharmacy settings
Open this folder and view contentsAnnex 8. National drug regulatory legislation: guiding principles for small drug regulatory authorities
Open this folder and view contentsAnnex 9. Provisional guidelines for developing training programmes: inspection and examination of counterfeit pharmaceuticals
View the documentWorld Health Organization Technical Report Series
View the documentSelected WHO Publications of Related Interest
View the documentBack Cover
 

Appendix 2. Guidance on sampling

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).

 

References

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.

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