News

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

Checking CEPs

Upon receipt of a certificate of suitability, check that it is complete i.e. all pages are present and all Annexes attached. Check the EDQM Knowledge Database to ensure that the CEP is current and valid. Before submitting the CEP to a competent authority, make sure that the Declaration of Access has been completed by the CEP holder, authorising you to use the document.

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.

 

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

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   

Search Real Regulatory