News

February 2022
Real CMC Tips and Insights

published 1 Mar 2022

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 February 2022 are collected here, for convenience. Make sure you follow  Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.

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

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.

 

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

January 2022 Real CMC Tips & Insights Round-Up: https://bit.ly/RealCMC-3vqun9e

November 2021 Real CMC Tips & Insights Round-Up: https://bit.ly/RealCMC-3MeSv4I

October 2021 Real CMC Tips & Insights Round-Up: https://bit.ly/RealCMC-3m6baEr

September 2021 Real CMC Tips & Insights Round-Up: https://bit.ly/RealCMC-3EHh5GU

August 2021 Real CMC Tips & Insights Round-Up: https://bit.ly/RealCMC-3aEoZn8

July 2021 Real CMC Tips & Insights Round-Up: https://bit.ly/RealCMC-3yRksaA

June 2021 Real CMC Tips & Insights Round-Up: https://bit.ly/RealCMC-3jtMtjb

May 2021 Real CMC Tips & Insights Round-Up: https://bit.ly/RealCMC-2V19DEX

March 2021 Real CMC Tips & Insights Round-Up: http://bit.ly/RealCMC-2SrciXD

February 2021 Real CMC Tips & Insights Round-Up: http://bit.ly/RealCMC-3uhFpcU

January 2021 Real CMC Tips & Insights Round-Up: http://bit.ly/RealCMC-3qgM2dp

December 2020 Real CMC Tips & Insights Round-Up: http://bit.ly/RealCMC-3jlAPGF

November 2020 Real CMC Tips & Insights Round-Up: http://bit.ly/RealCMC-3soERlp

October 2020 Real CMC Tips & Insights Round-Up:  https://bit.ly/RealCMC-3kbdPsv

September 2020 Real CMC Tips & Insights Round-Up: http://bit.ly/RealCMC-3k2PGEx

August 2020 Real CMC Tips & Insights Round-Up: http://bit.ly/RealCMC-32iYuAd

July 2020 Real CMC Tips & Insights Round-Up:  https://bit.ly/RealCMC-2XCrqk1   

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