February 2021
Real CMC Tips and Insights

published 4 Mar 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 February 2021 are collected here, for convenience. Make sure you follow  Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.

EMA Assessment Templates

Use the EMA's assessment templates when reviewing your Module 3 before submission. The templates will help you avoid serious setbacks during assessment and give you a better idea of your dossier's approvability. The Day 80 assessment report - Quality template with guidance, along with its annexes for assessment of ASMFs, is especially useful. Note that there are separate templates for generic products.

Use of Surfactant in Dissolution Media

​Dissolution media containing surfactant are often challenged by European assessors. Use surfactant at the lowest possible concentration, and only if absolutely necessary to achieve adequate release of poorly soluble drug substances. Be prepared with strong justification for the type and amount of surfactant used and with proof that the discriminatory power of the dissolution test remains adequate.

Class 2 Residual Solvents

The easiest way to know if your formulation is safe and approvable with regard to Class 2 residual solvents (solvents with known toxic potential) is to make sure each component meets the ICH Q3C Option 1 limit for each solvent. However, remember that Option 2 is also a valid approach when individual components do not meet Option 1 limits: you can use the permitted daily exposure for the solvent together with the maximum daily dose of the product to calculate an acceptable limit for the solvent in your medicinal product.


EudraGMDP ( is a very useful public database of pharmaceutical manufacturers, importers, and wholesale dealers, which can be used to verify GMP/GDP status but also (through the MIA/GMP Operations Search and the API Search) to identify sites approved to perform activities of interest. Historical data on UK sites remains in the database even now that the Brexit transition period has ended, but for more up-to-date information use the UK database with similar functionality: MHRA-GMDP (


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

January 2021 Real CMC Tips & Insights Round-Up:

December 2020 Real CMC Tips & Insights Round-Up:

November 2020 Real CMC Tips & Insights Round-Up:

October 2020 Real CMC Tips & Insights Round-Up:

September 2020 Real CMC Tips & Insights Round-Up:

August 2020 Real CMC Tips & Insights Round-Up:

July 2020 Real CMC Tips & Insights Round-Up:   

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