November 2020
Real CMC Tips and Insights

published 4 Dec 2020

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 November 2020 are collected here, for convenience. Make sure you follow  Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.

Finished Product Batch Sizes

For standard products and manufacturing processes, competent authorities will generally accept a range of batch sizes in the dossier and one can increase/decrease the batch size via a Type IA/IB variation. On the other hand, only fixed and validated batch sizes are typically accepted for non-standard products and processes and Type II variations are required to make changes.

Ph. Eur. Specifications and Test Methods

For drug substances and excipients described in Ph. Eur. monographs, the specifications and analytical procedures in the monograph are regarded as justified and validated and need not be presented in the dossier when submitting in the EEA; a reference to the monograph suffices. In general, no additional validation work needs to be included in the dossier, but note that there are exceptions! For example, suitability of microbiological quality test methods needs to be demonstrated and validation provided.

CEPs in the Dossier

When submitting a marketing authorisation application in the EEA, CEPs must be included twice in the dossier: in the eAF (Annex 5.10 or Annex 5.12) and in Module 3.2.R. The certificate numbers of CEPs for TSE are also listed in section 2.6.2 of the eAF. Inconsistencies in the information presented in these locations result in frequent validation errors upon submission.

Harmonised Monographs

Monographs that are harmonised between the Ph. Eur., JP and USP might not necessarily be completely interchangeable. In Ph. Eur. general chapters and monographs, any non-harmonised attributes are presented between wblack diamondsw. Local requirements (present only in Ph. Eur. and not the other pharmacopoeias) are presented between ◊white diamonds◊. Functionality-related characteristics are never harmonised.


For previous monthly round-ups, you can follow these links:

October 2020 Real CMC Tips & Insights Round-Up:

September 2020 Real CMC Tips & Insights Round-Up:

August 2020 Real CMC Tips & Insights Round-Up:

July 2020 Real CMC Tips & Insights Round-Up:   

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