October 2020
Real CMC Tips and Insights

published 6 Nov 2020

Since the beginning of August 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 2020 are collected here, for convenience. Make sure you follow  Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.

   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.

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 procedure

Ph. Eur. Status in Britain

Many people think that the Ph. Eur. is a publication of the EU. It is not! It is published by the Council of Europe, an organisation completely distinct from the EU. The United Kingdom remains a member of the Council of Europe and party to the Convention on the Elaboration of a European Pharmacopoeia irrespective of Brexit. Therefore, the Ph. Eur. remains legally binding in the UK.

Checking CEPs

Upon receipt of a certificate of suitability, check that it is complete i.e. all pages are present and all Annexes attached. Check the EDQM Knowledge Database to ensure that the CEP is current and valid. Before submitting the CEP to a competent authority, make sure that the Declaration of Access has been completed by the CEP holder, authorising you to use the document.


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

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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