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Chemical purity evaluation: it is a critical summary of the information provided in the application dossier. Emphasis will be made on the suitability of the European Pharmacopoeia monograph to control the quality of the concerned substance, the potential impurities from the specified manufacturing route and the need for alternative method when relevant. Particular attention will have to be given to justify cases where testing for impurities is omitted (eg. when an impurity will not potentially be present due to a particular route of synthesis)...

TSE risk evaluation: the QOS should discuss the ability of the system in place to minimise the risk of TSE for the substance especially traceability and aspect of the "3 pilars", (countries of origin, animal tissues and method of manufacture) with particular reference to general chapter 5.2.8. of the Ph. Eur., which is verbatim the EMEA NfG on minimising the risk of TSE.

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