« Le Penseur » vu sur son côté droit by Flickr user couscouschocolat

Last week’s round-up, 26-30 August 2019

By Tessa Fiorini-Cohen and Marthese Mifsud


Particulate Contamination: sub-visible particles in non-injectable liquid preparations

30 Aug 2019

A new draft chapter on particulate contamination by sub-visible particles in non-injectable liquid preparations has been released by the EDQM, within Pharmeuropa 31.4.

Two methods through which such particulate contamination can be detected are specified within it: a light obscuration particle count test and a microscopic particle count test. The former is the preferred test method, though the chapter does state that in certain cases both methods may need to be used sequentially. Stakeholders have until the 31st December to submit related comments:  http://bit.ly/RealGenerics-2ZBpJWn


Exporting active substance manufactured in the UK in a no-deal Brexit

29 Aug 2019

The MHRA has updated its guidance on active substance export in the case of a no-deal Brexit – this now includes a register of Written Confirmations for active substance manufacturers within the UK.

Written Confirmations state that a manufacturer’s GMP standards are equivalent to those in the EEA, the manufacturing plant is subject to regular inspections, and significant non-compliance events would be communicated to the EEA without delay. These have been generated by the MHRA for UK active substance manufacturers, whether they intend to export active substances or not. The Written Confirmations are valid for three years and can be used by manufacturers as and when required, to support export of active substances to the EEA in the case of a no deal Brexit: http://bit.ly/RealGenerics-2LbXDYy 


USP, British Pharmacopoeia Formalize Quality Standards Partnership

28 Aug 2019

The United States and British Pharmacopoeias have signed a memorandum of understanding, which formalises a partnership between the two entities.

The agreement establishes a framework for cooperative activities, including development of drug product monographs and knowledge sharing. The organisations also intend to exchange scientific staff, host joint events, and expand their previously informal collaboration into new areas: http://bit.ly/RealGenerics-2NBHsXp


Falsified Medicines and the supply chain – MHRA Inspectorate

27 Aug 2019

The MHRA’s latest blog post on falsified medicines notes that after an event involving falsified products, “staff often report that they had suspicions or thought that something unusual was occurring”. The post includes a list of warning bells, including rented delivery vans, unusual stock boxes which indicate that they might have been stored somewhere unexpected, and large orders suddenly becoming available.

The post also reminds readers that those sending stock for export should ensure that 2D barcodes are decommissioned, as otherwise these would scan through as acceptable packs upon re-entry: http://bit.ly/RealGenerics-2L8WZLr


Critical Thinking and Leadership Skills for Regulatory Professionals

26 Aug 2019

Are critical thinking and leadership more important than technical skills for today’s regulatory affairs professionals?

A recent article published in Regulatory Focus takes the position that this is indeed so, especially the higher up a person goes in an organisation. Regulations, medical terms and statistical help can be easily found on the internet, but critical thinking and leadership are qualities that must be learned and practiced. The author reviews these skills from the perspective of regulatory affairs, and explains how each can be nurtured: http://bit.ly/RealGenerics-2ZvcEOi

Image: « Le Penseur » vu sur son côté droit by CC BY 2.0

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