December 2020
Real CMC Tips and Insights

published 14 Jan 2021

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

Identification Tests

ID tests must be specific e.g. IR spectroscopy. Chromatographic retention time is not an acceptable ID test if used by itself, but it is acceptable if hyphenated analytical methods (e.g. LC-DAD or LC-MS) or two different chromatographic procedures where separation is based on different principles are used. For salts, if the ID test is not specific for the salt as a whole, specific ID tests for the individual ions are required


Assessor Convenience

When compiling Module 3 and the QOS, put yourself in the assessor’s shoes and think! The assessor is a person not a robot. What can you do to make their life easier (and therefore more sympathetic when assessing)? Some examples: Make sure all scans are clear and legible. Rotate pages so that everything is the right way up. Think of summary tables you might include in the QOS that the assessor could copy unchanged into the assessment report. Add hyperlinks to facilitate navigation.


Non-Mandatory Sections of Ph.Eur. monographs

If you think that all of a Ph. Eur. monograph is mandatory, you’ll be surprised to know that it isn’t! The description of the material in the Characters section, the recommendations in the Storage section, and the Functionality-Related Characteristics are not mandatory requirements. (However, it is advisable to include relevant functionality-related characteristics in the excipient specification and competent authorities might insist on this.) In the Labelling section, only those statements necessary to demonstrate compliance are mandatory.


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

November 2020 Real CMC Tips & Insights Round-Up:

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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