News

August 2021
Real CMC Tips and Insights

published 7 Sep 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 August 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.

 

Finished product assay limits

Finished product assay limits at release of ±5% are acceptable in the EU without further justification. Wider limits (even if based on pharmacopoeial monographs) have to be soundly justified based on production variability, the analytical test procedure, stability data and other relevant considerations. This differs from the North American norm, where assay limits at release are typically ±10%.

 

Ingredients in the eAF

When preparing to submit a European MAA, make sure that the dropdown lists in the eAF include all the ingredients your formulation contains. If not, you will need to get in touch with EMA in advance to get the ingredient included in the lists. So don’t leave it till the last minute

 

Acceptance criteria for microbiological quality

Ph. Eur. and USP acceptance criteria for microbiological quality are interpreted as follows: - 101 CFU: maximum acceptable count is 20 not 10 - 102 CFU: maximum acceptable count is 200 not 100 and so on. This seems counterintuitive, but the leeway is meant to allow for the poor accuracy and precision of microbiological enumeration.

 

 

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

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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