News

May 2021
Real CMC Tips and Insights

published 16 Jun 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 May 2021 are collected here, for convenience. Make sure you follow  Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.

Leaching and Sorption

Interaction studies identify any unacceptable effects of packaging materials and drug substance/product on each other. In Europe, interaction studies might be required for solid drug products intended for inhalation, parenteral or ophthalmic administration but not other solids. Migration studies are needed for non-solid drug substances and drug products whenever extraction studies have identified the presence of one or more extractables. Sorption studies are needed for non-solid drug products when changes observed during stability studies might be due to interaction with packaging materials.

Secondary & Tertiary Packaging

Module 3.2.P.7 of the dossier should focus on primary packaging - the packaging that comes into direct contact with the product. Secondary packaging should only be described briefly, unless it is functional (providing additional protection or serving to deliver the product). If functional, additional relevant information should be provided, such as a specification. No information on tertiary packaging should be presented.

Cross-Checking of Formulae

Inconsistencies between unit formulae in 3.2.P.1 and manufacturing formulae in 3.2.P.3.2 are very common. Make sure that the quantities in the formulae can easily be converted into each other by multiplying or dividing by the number of dosage units in the batch. To minimise the effect of rounding, derive the unit formula from the batch formula and not the other way round, and choose an appropriate number of decimal places. Also check the total weights or volumes - do the quantities in your composition tables add up to the stated totals? Have density, overfills and overages been taken into consideration and clearly stated?

 

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

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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