Strategy for Pooled Procurement of Essential Medicines and Health Commodities, 2013-2017 1 Quality assurance The quality assurance of pharmaceutical products is a wide-ranging concept that covers all matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made to ensure that pharmaceutical products are of the quality required for their intended use. Quality control The quality control of pharmaceutical products is a concept that covers all measures taken—including the setting of specifications, sampling, testing and analytical clearance—to ensure that the raw materials, intermediates, packaging materials and finished pharmaceutical products conform with established specifications for identity, strength, purity and other characteristics. Tracer medicines Medicines selected by the surveyors in the 2010 Pharmaceutical Marketing Analysis study, of which the assembled data form the baseline for measuring implementation of the Strategy. Standardisation Standardisation is the process of establishing a technical standard, which could be a standard specification, standard test method, standard definition, or standard procedure. Standardisation means that there is a standard specification, unit, instruction or characteristic that is understood globally. Work sharing The sharing of “good practices”, as laid down in guidelines, standard operating procedures (SOPs), standard bidding documents, tender adjudication reports, storage conditions, distribution schedules, etc. See http://www.who.int/trade/glossary/story078/en/index.html [accessed 4 April 2013] 5

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