Quality control
The term quality control refers to the sum of all procedures undertaken to ensure the identity and purity of a particular pharmaceutical. Such procedures may range from the performance of simple chemical experiments which determine the identity and screening for the presence of particular pharmaceutical substance (thin layer chromatography, infrared spectroscopy, etc.), to more complicated requirements of pharmacopoeial monographs. Activities extend to the area of quality control laboratories (good laboratory management practices, models, e.g. for certificate of analysis and lists of laboratory equipment, and an external assessment scheme.
Screening tests
Pharmacopoeia and International Reference Standards
- The International Pharmacopoeia (Ph.Int.)
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Index of national, regional and international pharmacopoeias
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Development of monographs for The International Pharmacopoeia
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Annex 1, WHO Technical Report Series 970, 2012 - International Chemical Reference Substances (availability, price, ordering)
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Release procedure for International Chemical Reference
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Annex 1, WHO Technical Report Series 981, 2013 -
Recommendations on Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products [pdf 632kb]
pdf, 45kb
Annex 1, WHO Technical Report Series 908, 2003 -
The International Pharmacopoeia: revised concepts and future perspectives [pdf 632kb]
pdf, 81kb
Annex 2, WHO Technical Report Series 908, 2003 -
The International Pharmacopoeia – related substances tests: dosage form monographs guidance notes
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Annex 1, WHO Technical Report Series 943, 2007 -
General guidelines for the establishment, maintenance and distribution of chemical reference substances
pdf, 126kb
Annex 3, WHO Technical Report Series 943, 2007
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PowerPoint presentation on the International Pharmacopoeia
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Release procedure of International Chemical Reference Substances
pdf, 59kb
Annex 1, WHO Technical Report Series 961, 2011
Monographs for International Pharmacopoeia
Analysis of Samples
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Considerations for requesting analyses of drug samples
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Annex 4, WHO Technical Report Series 902, 2002 -
Model certificate of analysis
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Annex 10, WHO Technical Report Series 902, 2002
Laboratory Guidelines
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Good practices for pharmaceutical quality control laboratories
pdf, 180kb
Annex 1, WHO Technical Report Series 957, 2010 -
WHO good practices for pharmaceutical microbiology laboratories
pdf, 160kb
Annex 2, WHO Technical Report Series 961, 2011 - Quality Control Training Modules
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Prequalification of quality control laboratories. Procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies
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Annex 12, WHO Technical Report Series 961, 2011 -
WHO guidelines for preparing a laboratory information file
pdf, 73kb
Annex 13, WHO Technical Report Series 961, 2011