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The verification and validation of pharmacopoeial methods

The analytical examination of raw materials, auxiliary materials and active ingredients, from examination on receipt to approval for the market, is important for the quality of drugs. For them to be approved, it must be ensured that the necessary quality checks are carried out in accordance with regulations and that they fulfil the regulatory requirements of the relevant market. Tests of raw materials are designed on the basis of official pharmacopoeias such as the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopoeia (USP). For drugs and active ingredients, the product-specific testing guidelines registered with the authorisation dossier are applied together with the corresponding specifications. The individual methods of analysis should be verified or validated depending on the complexity of the analysis and the type of substance under analysis. This article will tell you what to look out for. 

UFAG Laboratorien AG is a leading independent Swiss contract laboratory for pharmaceutical analysis, and possesses infrastructure, equipment and expertise that allow it to meet all the needs of the pharmaceutical industry. For our customers, we are a competent contact to which they can address all their analytical questions.  

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Verifizierung und Validierung von Arzneibuchmethoden
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