These guidelines provide advice on the quality management system within which the analysis of active pharmaceutical ingredients (APIs), excipients and pharmaceutical products should be performed to demonstrate that reliable results are obtained.
Compliance with the recommendations provided in these guidelines will help promote international harmonization of laboratory practices and will facilitate cooperation among laboratories and mutual recognition of results.
Special attention should be given to ensure the correct and effi cient functioning of the laboratory.
Planning and future budgets should ensure that the necessary resources are available inter alia for the maintenance of the laboratory, as well as for an appropriate infrastructure and energy supply. Means and procedures should be in place (in case of possible supply problems) to ensure that the laboratory can continue its activities.
Continue at: http://apps.who.int/medicinedocs/documents/s18681en/s18681en.pdf
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