Last week’s round -up;
06 -10 September 2021

published 13 Sep 2021

Comments concerning revised texts published in Supplement 10.7

Ph. Eur. Supplement 10.7 is now available and will become effective on 1 April 2022. Some of the revised texts include the following general chapters and general monographs:

• General notices

• 2.2.48. Raman spectroscopy

• 5.1.3. Efficacy of antimicrobial preservation

• 5.4. Residual solvents

• Vaccines for human use (0153)

• Liquid preparations for cutaneous application (0927) Several active pharmaceutical ingredient monographs have also been updated.

The technical modifications can also be consulted in the Knowledge database under ‘View history’.

Revised EDQM guidance for electronic submissions for CEP applications

The EDQM has issued an updated “Guidance for electronic submissions for Certificates of Suitability (CEP) applications” to reflect the current practices to facilitate eCTD submissions for CEPs. One important recommendation in the revised guidance is that when switching to the eCTD format from another format, it will be mandatory to include any information already assessed and approved previously in a ‘baseline (full dossier)’ to facilitate lifecycle management. This update will be implemented by January 2022, however, the Directorate recommends that applicants implement this recommendation as soon as possible. The revised guidance also includes some clarifications regarding specific topics such as the submission of grouped revisions and examples of format issues hindering the receipt of applications.

Warning to pharmaceutical industry on nitrosamine risk assessments

During an IPEC webinar, the pharmaceutical industry was advised to closely evaluate suppliers’ testing and question dubious results to ensure that accurate methods are being used to assess nitrosamine risks in drug products. The warning was issued following a recent case where a supplier outsourced the testing of an excipient to a contract laboratory, due to a lack of in-house testing capabilities. The test results exceeded acceptable thresholds for each of the six nitrosamines tested. After a “lot of dialogue” between the supplier and the contract lab, the contract lab reviewed their testing documents and findings and subsequently uncovered errors in the testing. The lab retested the samples and found the excipient was actually within acceptable limits.

New draft Ph. Eur. 2.9.48 on Particle Size and Shape Determination by Image Analysis

A new draft Ph. Eur. monograph on Particle Size and Shape Determination by Image Analysis has been published in Pharmeuropa 33.4 for public consultation until the 31st December 2021. Image analysis is a computer-based technique used to determine the size and shape of particles from digital images efficiently and reliably. The images may be obtained by several techniques including optical microscopy, chemical imaging or electron microscopy. The measuring principle is based on a discretisation of an image into ‘pixels’, which are calibrated with respect to size and a software algorithm assigns the pixels to individual particles, which are thus characterised by a defined number of pixels of known size. The new guidance covers both static and dynamic image analysis. The dynamic technique can measure more particles than in static image analysis and is more reliable for wide size distributions, however, the technique is prone to systematic errors with respect to size.

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