News

November 2021
Real CMC Tips and Insights

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

 

Ph. Eur. Status in Europe

As the official pharmacopoeia in the European Economic Area (complemented by national pharmacopoeias where relevant), the Ph. Eur. helps define the requirements to obtain a marketing authorisation. The quality standards it contains are legally binding. However, appropriately validated, alternative test methods (though not specifications) can be submitted for approval by competent authorities during MA application procedures.

 

Reporting Organic Impurity Content

For impurities <1.0%, report results to two decimal places (e.g. 0.06%, 0.13%).  For impurities ≥1.0%, report results to one decimal place (e.g. 1.3%). All impurities above the reporting threshold should be summed and reported as total impurities. When comparing to a reporting, identification or qualification threshold, the result should first be rounded to the same decimal place as the threshold. Thresholds have to be exceeded to apply.

 

Polymorphism

For polymorphic drug substances, you need to demonstrate that: 1. The same form of the drug substance is consistently synthesized and does not change during the retest period. 2. Conversion to a different form does not occur during finished product manufacture and shelf-life. If conversion does occur, you will have to show that product performance, safety and efficacy are not affected.

 

Specifications in the Dossier

Specifications presented in a marketing authorisation application should be numbered and dated. Many assessors will insist on this, and it is good practice in any case, for traceability. It is advisable to create an SOP laying out the numbering system and linking back to in-house specifications.

 

 

 

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

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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