December 2022
Real CMC Tips and Insights

published 3 Jan 2023

Since the beginning of July 2020, we have published weekly Regulatory tips and insights from our Regulatory experts on our Real Regulatory LinkedIn page, as a service to our followers. The tips we published in December 2022 are collected here, for convenience. Make sure you follow  Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.


SOPs in the Dossier

Resist the temptation to include SOPs in an IMPD or Module 3. SOPs invariably contain excess information that is not relevant to a regulatory application. Instead, get an experienced regulatory technical writer to pare down your manufacturing and analytical procedures to the essentials for presentation in the dossier.


Mass Balance

Take a long, hard look at your stability results. Is any reduction in assay accompanied by a corresponding increase in degradation products? If not, you have a mass imbalance which you should investigate thoroughly. Mass imbalances are normally due to analytical deficiencies but can happen for other reasons e.g. API sublimation.


Reviewing an IMPD or Module 3

When preparing to submit a clinical trial or marketing authorisation application, get one experienced reviewer to read the IMPD or Module 3 from cover to cover. In our experience, he or she will uncover a surprising amount of inconsistencies that reviewers of individual sections will not catch.



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