January 2021
Real CMC Tips and Insights

published 2 Feb 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 January 2021 are collected here, for convenience. Make sure you follow  Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.

Batch Analyses

Batch analyses for drug substance and drug product presented in a European CTD should include full testing i.e. results for all specified parameters. When possible, the batches should be consecutive and full-scale, manufactured and tested in accordance with the process and analytical procedures being registered. Preferably, the various proposed manufacturing sites should all be represented. Results for at least two batches are normally requested by assessors

Bulk Hold Time

Bulk hold time refers to the designated storage time of intermediate products (e.g. granules, uncoated tablets, bulk coated tablets) before they undergo further processing. Any storage time in excess of 30 days for solid oral dosage forms and 24 hours for sterile products is considered as prolonged storage or process time and must be supported by bulk stability studies at the relevant storage conditions.

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

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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