Sabine Paris

A GMP DIALOGUE of the GMP Conference, the GMP BERATER Tage, in October 2019 was entitled "Basic GMP questions and answers". Here, the questions could be asked to which the participants always wanted to have an answer. The two experts provided answers in the course of a lively discussion.

Are you already training online or still offline? What do the employees, the management, the works council and other stakeholders want? How can this be controlled and GMP-compliant? How can blended learning be implemented?

Manufacturing is the origin of Good Manufacturing Practices - here is the core cell of GMP compliance. Many things must be observed and continuously implemented correctly. How do you deal with the challenges of everyday production? Who bears what responsibility? What can be delegated? How do you deal with deviations?

It's been 12 months since EU FMD came into force and after initial problems bedding in the new systems, false alerts remain a problem, preventing the realisation of the full benefits of the Directive. With many grace periods now coming to an end, where are manufacturers on the EU FMD journey and what are the real consequences of unresolved alerts moving forward? Grant Courtney of Be4ward examines the reasons behind these alerts occurring and looks at the action stakeholders must take now to keep the supply chain flowing.

For almost 30 years now, the PDA/FDA Joint Regulatory Conference has been taking place once a year. From 14 to 16 September 2020 it was a virtual-only event for the first time. The title of the conference was "The Future Is Now: Effective Quality Management and Robust Manufacturing".

For all of us, the year 2020 turned out quite differently than we had ever imagined. People everywhere are struggling with new challenges. The GMP world was not spared, either. To name just a few: inspections were carried out remotely to a large extent and many regulations remained in draft form for the time being.

The deficiency

Time specifications for the start of production (preparation from 8:30) and for the end of production (15:30) were entered in the batch documentation.

The PDA/FDA Joint Regulatory Conference, which is now in its 30th year, took place as a virtual event from September 27 – September 29. The Conference focused on the role of effective quality systems in ensuring an ongoing state of control throughout the product lifecycle by vigilantly managing risks to manufacturing and quality.

The PDA/FDA Joint Regulatory Conference, which is now in its 30th year, took place as a virtual event from September 27 – September 29. The Conference focused on the role of effective quality systems in ensuring an ongoing state of control throughout the product lifecycle by vigilantly managing risks to manufacturing and quality.

"Contaminants in medicinal products – focus on nitrosamines" was the title of an online training course organised by the German FORUM Institute on 12 November 2021. Four renowned experts from the authorities, industry and consulting shed light on all aspects of nitrosamines that play a role in the life cycle of a medicinal product.

The new Annex 21: Importation of medicinal products to the EU GMP Guide has been published on February 21, 2022 and will enter into force on August 21, 2022. The 6-page annex summarises the GMP requirements for Manufacturer/Importer Authorisation (MIA) holders to import medicinal products (human, investigational and veterinary) from outside the EU/EEA (we reported).

The Swiss Biotech Day 2023 took place on 24 and 25 April in Basel. The conference is one of the industry's most important meeting places for developers and manufacturers of biopharmaceuticals and is growing in popularity every year.

The monograph on Cannabis flower (3028) has been published in Ph. Eur. Supplement 11.5 in January 2024, with an implementation date of 1 July 2024. 
All member states of the European Pharmacopoeia are required to replace their national monographs with this new Ph. Eur. Monograph. 

In 2015, with the revision of Chapters 3 and 5 and Annex 15 of the EU GMP Guide and with the publication of the EMA PDE Guideline a paradigm shift occurred in the setting of limits for the validation of cleaning processes. Instead of the previously used criteria, such as 10 ppm or 1/1000 of the therapeutic dose of the foregoing product, the only acceptable criterion is now a toxicological risk assessment based on PDE values.

Reading SOPs is not Training! This powerful statement was echoed in several sessions with the PDA/FDA Joint Regulatory Conference 2024. It highlights a critical point: training is more than just reading procedures – it requires performance evaluation. Sabine Paris and Thomas Peither attended the event and have highlighted some of the other key takeaways in today’s feature.

In today’s feature, our editor Sabine Paris reports from the PDA Good Aseptic Manufacturing Conference 2025 in Basel, where Swissmedic's Paula Walser provided valuable regulatory perspective alongside industry experts. The conference revealed that 25 % of companies remain non-compliant with Annex 1, facing challenges from cleanroom upgrades to contamination control strategies. However, speakers from Takeda, Novartis, and Charles River demonstrated how regulatory pressure is driving innovation – from questioning traditional monitoring methods to advancing digital transformation of sterility testing and rapid microbiological methods. The blend of regulatory insight and industry innovation showcased how Annex 1 compliance is reshaping aseptic manufacturing.