Last week’s round-up;
14 – 18 September 2020

published 21 Sep 2020

Investigations in the GMDP environment

The MHRA Inspectorate has released a blog post on the most common issues related to investigations in the GMP and GDP environment that are encountered during inspections. The aim of the article is to help pharmaceutical manufacturers and wholesalers improve the outcome of their investigations, and it is applicable to deviations, customer complaints and other Pharmaceutical Quality System (PQS) activities. Several issues that may be encountered during investigations are covered, as well as the relevant implications on CAPA systems, risk assessments, patient safety and root cause analysis.

EMA:  Clinical Data Publication temporarily suspended – except for COVID-19 related products

EMA suspended all new activities related to the publication of clinical data on 1st Aug 2018. This was done as a result of the implementation of the third phase of EMA’s business continuity plan during the relocation of its offices from London to Amsterdam. However, the agency has just clarified that the suspension of clinical data publication does not apply to COVID-19 related products, in line with EMA’s exceptional transparency measures for treatments and vaccines for COVID-19. Pharmaceutical companies should contact EMA as soon as possible concerning publication of clinical data if they plan to submit an application for a COVID-19 related product.

Further details can be found under this link:

EC:  Proposed European agency for biomedical advanced research and development

The EC President Ursula von der Leyen yesterday (16th Sept 2020) gave her state of the union address, in which she called for lessons to be learned from the current pandemic. She asserted that Europe must build a stronger European health union, with a future-proof and properly funded EU4Health programme, a reinforced European Medicines Agency (EMA) and a strengthened European Centre for Disease Prevention and Control (ECDC). The President also pledged to build a European agency for biomedical advanced research and development to enhance Europe’s capacity to respond to cross-border threats and called for a debate on new competences for the EU in the field of health, as part of the forthcoming Conference on the Future of Europe.

Full details of the address can be found under this link

USP General Chapter <1469> Nitrosamines – Public consultation

A new USP general chapter <1469> Nitrosamines has been proposed. The aim of this standard is to ensure the appropriate control of potentially carcinogenic nitrosamine impurities, eliminating or reducing their presence in drug products and drug substances. This USP chapter also covers potential sources of nitrosamines, risk assessments, nitrosamine limits, testing and analytical procedures, test method performance characteristics of nitrosamine methods and USP reference standards. The chapter has been published in draft form in Pharmacopoeial Forum 46(5) and is open for public consultation until the 30th November 2020.

Biotherapeutics Ph. Eur. Monographs Updates

The EDQM has updated its Ph. Eur. monograph portfolio on Biotherapeutics. Several monographs are under revision and the EDQM intends to emphasise “greater flexibility as a means of better addressing the structural complexity and naturally occurring heterogeneity of these substances, and the potential diversity of the preparation resulting from different manufacturing processes”. Several individual Ph. Eur. monographs are also under revision including Erythropoietin concentrated solution, Follitropin, Follitropin concentrated solution, Human coagulation factor VIII rDNA, Somatropin concentrated solution, Somatropin, Somatropin for injection and Somatropin solution for injection. The Ph. Eur. Biotherapeutics portfolio also includes a list of new monographs that are currently in preparation. Since the portfolio was published, the revised version of Erythropoietin concentrated solution (1316) monograph has been adopted. The updates include several changes which bring about a significant improvement in the analytical performance of the monograph, while also providing the sought-after flexibility. The updates to the monograph are discussed in the following link:

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