Last weeks’ round -up;
31 May – 11 June 2021

published 15 Jun 2021

Draft revised Ph. Eur. General Chapter 2.8.2 on Foreign Matter

A draft revised general chapter on Foreign Matter (with tracked changes) has been published in Pharmeuropa 33.3 and is available for comment until the 30th September 2021. Requirements for other foreign elements like moulds, insects and other animal contamination have been further specified in the revised chapter which may be viewed at the following link:

Comments concerning revised texts published in Supplement 10.6

The EDQM has released information regarding the technical modifications that have been made to revised Ph. Eur. texts adopted by the European Pharmacopoeia Commission at the November session and published in Supplement 10.6. Modified texts are indicated by horizontal or vertical lines in the margin of 10.6. The details given in the article linked below complete this information but are not necessarily exhaustive. The details concerned may also be consulted in the Knowledge Database under View History.

UK-Canada mutual recognition of GMP certificates and batch testing continues

The MHRA has confirmed that Canada and the UK will continue to recognise Certificates of Good Manufacturing Practice (GMP) Compliance issued by each country’s regulatory agencies and to accept batch testing certificates held by a manufacturer without re-control of that batch at import, following entry into force on 1 April 2021 of the comprehensive UK-Canada Trade Continuity Agreement (TCA) entered into force on 1 April 2021. For further details and a link to the TCA itself, please see the MHRA page at the following link:

New Ph. Eur. general chapter on cell-based assay for potency determination of TNF-alpha antagonists

A new draft general chapter on cell-based assay for potency determination of TNF-alpha antagonists (2.7.26) has been published in Pharmeuropa 33.2 and is open for public consultation until 30th June 2021. This new general chapter is the first in a series of three planned new “horizontal standards” for therapeutic monoclonal antibodies (mAbs). It covers the execution of four specific cell-based assay procedures and provides considerations on data analysis, system suitability, assay acceptance criteria and results evaluation, as well as best practices for the adjustment of assay conditions, addressing certain critical aspects.

Revised Ph. Eur. General Chapter on Particulate Contamination: Sub-visible Particles

A revised general chapter 2.9.19. Particulate Contamination: Sub-visible Particles has been published in Pharmeuropa 33.2. This revised chapter is the result of discussions held between the Japanese Pharmacopoeia and the United States Pharmacopoeia within the Pharmacopoeial Discussion Group (PDG). The revised chapter includes a harmonised procedure for each of the analytical procedures described and includes the following changes: the light obscuration particle count test allows the use of sample volumes less than 5 mL depending on the instrument capability, the microscopic particle count test no longer requires at least 10 units to be combined for small volume preparations, and a combination of fewer units for this test is permitted depending on instrument capability and sample properties. The chapter is open for public consultation until 30th June 2021.


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