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Chemical purity evaluation: it this is a critical summary of the information provided in the application dossier. Emphasis will be made placed on the suitability of the European Pharmacopoeia monograph to control the quality of the concerned substance, the potential impurities (including nitrosamines and elemental impurities) resulting from the specified manufacturing route and the need for alternative method when relevantmethods where appropriate. Particular attention will have to be given paid to justify justifying cases where testing for impurities is omitted (ege.g. when if an impurity will not potentially is unlikely to 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 TSE risk of TSE for the substance, especially concerning traceability and aspect of the "3 pilars"the ‘3 pillars’, (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 identical to the EMEA  EMA NfG on minimising the risk of TSEtransmitting TSEs.