News

October 2021
Real CMC Tips and Insights

published 3 Nov 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 October 2021 are collected here, for convenience. Make sure you follow  Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.

Mass Balance

Take a long, hard look at your stability results. Is any reduction in assay accompanied by a corresponding increase in degradation products? If not, you have a mass imbalance which you should investigate thoroughly. Mass imbalances are normally due to analytical deficiencies but can happen for other reasons e.g. API sublimation.

 

SOPs in the Dossier

Resist the temptation to include SOPs in an IMPD or Module 3. SOPs invariably contain excess information that is not relevant to a regulatory application. Instead, get an experienced regulatory technical writer to pare down your manufacturing and analytical procedures to the essentials for presentation in the dossier.

 

Reporting Impurities

Any impurities present above the reporting threshold should be reported individually. Reporting a ‘maximum observed impurity’ provides very little information on the analyte’s impurity profile, especially when trying to observe trends during stability studies. For in-house evaluation, it is preferable to individually report all impurities at or above the LOQ

 

Dissolution Profiling of Biobatches

Study the dissolution profiles of your bioequivalence study batches in as many media using as many different test parameters as possible. Characterisation of biobatch dissolution will form the basis for your dissolution specifications throughout your product’s lifecycle. The more information you collect, the more thankful you’ll be years down the line. 

 

 

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

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