According to EU GMP Guide Part II (ICH Q7) an API starting material is a raw material, an intermediate, or an API that is used in the production of an API and is incorporated as a significant structural fragment into the structure of the final API. From this point on, appropriate GMP has to be applied to the API manufacturing steps.
In a marketing authorisation application the applicant has to describe in an ASMF the API manufacturing process. The “API regulatory starting material” has to be clearly designated and the rationale for the point at which the production of the API begins has to be documented. Same applies for a CEP application procedure.
In the last few years assessors have been more and more challenging the proposed regulatory starting materials. E.g. the definition of a starting material has been one of the top deficiencies in CEP applications. This is partly due to the fact that companies tend to describe shorter synthetic routes starting from complex starting materials. Moreover, changes of critical quality attributes and the request from the authorities to re-define the starting material can create difficult situations regarding additional efforts and significant delays in the application process.
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