Last week’s round-up;
24 – 28 August 2020

published 31 Aug 2020

Aseptic Processing Practices: Reviewing Three Decades of Change

Thought-provoking article by Agalloco, Akers and Madsen highlighting challenges that are emerging for 2020 and beyond for aseptic processing and arguing that it is time to revise the pharmaceutical industry’s expectations and approaches to validation. In the authors’ own words, “Technologies in use and on the horizon could change aseptic processing in ways that seemed inconceivable years ago but approaches to aseptic process validation still need to move beyond their 1970s roots.”

EMA’s Lapatinib product-specific bioequivalence guidance

The EMA has released a 2nd draft of its product specific guidance on the demonstration of the bioequivalence of lapatinib 250 mg film-coated tablets. The guidance was extensively revised following the first public consultation. Stakeholders may submit their comments on the revised draft guidance by the 30th October 2020.

EMA interactive guidance on IRIS access

The EMA has released an interactive presentation on how to register for their IRIS system, which gives a step by step guide to gaining access, and also information on some submission-specific requirements.

MHRA reflection on cross-contamination control

The MHRA has shared its reflections on some of the common factors in critical deficiencies found in control strategies for cross contamination between products in shared facilities. The Agency’s expectations are focussed mainly on sites handling products with lower level Health Based Exposure Levels (HBELs), those with products around the red area of the continuum seen in the PIC/S Q&A document. The MHRA has highlighted the following aspects that companies are required to address:

• HBELs should be completed by experienced professional toxicologists for all products

• The HBEL value and hazard knowledge should be used to set the context and the reference for conducting Quality Risk Management development of Organisational and Technical controls

• Companies may rely solely on visual inspection for cleanliness at changeover between products following cleaning validation, only when there is clear and safe evidence that residues can be consistently and readily seen at the acceptance criteria level

Further details on the MHRA’s expectations may be viewed at the following link:

Nitrosamines risk assessment: update for CEP holders

The EDQM has decided not to extend the deadline of 31st July 2020 for CEP holders to submit step 1 of the nitrosamine risk assessment for their APIs. The Directorate has said that “risk assessments for the presence of nitrosamines in active substances should be available early enough to allow MAHs to collect the relevant data for their medicinal products. In addition, most CEP holders have already completed this step.” CEP holders who have yet to submit their risk assessment and need support are required to contact the EDQM as soon as possible and should propose a justifiable timeline. As of 1st October 2020 applicants and CEP holders are also required to include a risk assessment regarding the potential formation of nitrosamines in any new CEP application, sister file or renewal application, and also in any revision where a risk of nitrosamine formation may be introduced. Applicants are advised to include the risk assessment in the CEP submission, even in cases where a risk is not identified.

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