#starting material

API starting materials – New Q&A document for ICH Q11

The selection of a starting material for the synthesis of an active substance and its justification is often one of the most crucial steps in the approval process. Assessors at regulatory agencies of the EU member states have to evaluate whether the data provided sufficiently justify the selection. The criteria for this are outlined in the 2012 ICH Q11guideline – however, not in a sufficiently…

Starting Material for API manufacturing: EMA expectations

The description of manufacturing process is an integral part of an approval dossier’s quality documentation for an API. According to the current regulation the applicant has to define his starting material and justify his selection.

However disagreements between applicants and quality assessors on the suitability of proposed starting materials have become more frequent in recent times. This…