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CITY of BLACK DIAMOND SENSITIVE AREA DETERMINATION FORM B D M

CITY of BLACK DIAMOND SENSITIVE AREA DETERMINATION FORM B D M

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[Music] DMF section 3.2.4 control of drug substance the DMF in ctd format consists of seven sections in this video we will talk about section 3.2.4 which will describe how the manufacturer performs the quality control of the AP this section is divided in five parts specification methods valid validations batch analysis and justification of specification the information needs to be coherent throughout these different subsections and also in line with the previous DMF sections for example if the impurity section describes that a certain impurity is controlled in the API specification this should be reflected here we don't want any surprises here regarding the control of impurities because in theory everything was already well explained in the previous section so we know what to expect this section starts with the API specification that is all the tests which are performed in routine for each batch of the API which is produced to decide whether or not that batch is approved if the

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