News

September 2021
Real CMC Tips and Insights

published 15 Oct 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 September 2021 are collected here, for convenience. Make sure you follow  Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.

Reduced testing of starting materials

Reduced or skip-lot testing of starting materials (APIs, excipients and packaging materials) is fully covered by EU GMP and is not product-specific. Therefore, in the relevant specifications in the MA application you should not include any reference at all to reduced testing on receipt by the finished product manufacturer. CMC assessors will object if you do.

Compatibility

Section 3.2.P.2.6 of the CTD is only applicable if reconstitution diluents or dosage devices are required to administer the product. Information on the compatibility of the drug product with any diluents or devices (e.g. precipitation, sorption, stability) should be provided. Compatibility with excipients and the container closure system is tackled elsewhere.

Updating a QOS

It is good practice to keep your Quality Overall Summary fully updated at all times, even if not strictly required by competent authorities. When done properly, the QOS focuses on the salient points of Module 3 and can be used to quickly familiarise staff, QPs and consultants with a product (as well as to refresh one’s memory!)

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.

 

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

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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