Aseptic Manufacturing of Medicinal Drug Products - Guidelines and Trends

In recent years, the aseptic manufacture of medicinal products has undergone considerable development as a result of both new regulatory requirements and technological advances. These changes affect many areas of pharmaceutical production, quality assurance and quality control.

Updated guidelines

The comprehensive revision of Annex 1 of the EU GMP guidelines in August 2022 introduced stricter requirements for sterility and product quality. The new regulations came into force on 25 August 2023; requirements for lyophilisation and product transfer have been mandatory since 25 August 2024. Other relevant guidelines, such as the German ADKA, are also currently being revised in order to fulfil higher quality standards and improve patient safety. As a result of the Annex 1 revision, in which various countries and authorities outside the EU were involved for the first time (FDA, WHO, Australia, etc.), revised guidelines on the manufacture of sterile products were also published by the WHO, the PIC/s and now also the Chinese authorities, all of which are close to the content of Annex 1. Even organisations such as the USP are drafting new chapters, for example <1110> on topics such as Contamination Control Strategy. As a result, modern standards are also being adopted in the USA, whose Aseptic Guide dates back to 2004 and is probably in need of revision.

Technological developments

Barrier isolators and RABS (Restricted Access Barrier Systems) have become established and, according to the new Annex 1, are a standard requirement for new authorisations. They enable a clear separation between product and personnel and thus reduce the risk of contamination. Automated, gloveless isolators are the way forward - especially for small batches in cell and gene therapy.

Wide-ranging effects

The implementation of the stricter EU requirements does not only have technical implications. In the short term, there were production and supply bottlenecks in some areas, such as sterile saline solutions, as many manufacturers were unable to fulfil the new requirements immediately.
Overall, the developments have improved product quality and safety, but also present manufacturers and healthcare facilities with new challenges. Continuous adaptation to new guidelines and technologies is therefore essential.

Key topics at the PharmaCongress 2025

These challenges are also a central theme of the GMP PharmaCongress 2025 with the accompanying PharmaTechnica Expo. The focus will be on classic topics such as aseptic technologies, isolators, barrier systems and single-use components, as well as on modern topics such as digitalisation, artificial intelligence, ATMPs and the quality and safety of medicinal cannabis.

Dr Maite Durrenbach, Chief Quality Officer at Sanofi, will kick off the event on 8 April 2025. She will present a company-wide system for integrated quality management, describe AI applications and the digitalisation of quality documentation - including video SOPs and electronic forms - and explain the key performance indicators and targets used.

Cleanroom issues and consumables

Although RABS and isolators cover the most critical processes, traditional cleanrooms remain in use. A separate conference track is therefore dedicated to cleanroom practice: suitable materials, monitoring and hygiene measures.
Everyday disposable products such as bonnets, gloves, masks and wipes are also essential for product quality. Incorrect selection or use can lead to contamination. Experts and a GMP inspector will explain the requirements and regulatory recommendations in this area, which has so far been subject to little regulation.

Sustainability and practical relevance

The congress will be rounded off by a two-day series of lectures on sustainability in pharmaceutical production and quality. This will also highlight the fact that digitalisation, automation and the use of AI will be an important aspect of the PharmaCongress 2025.

In total, the event on 8 and 9 April 2025 will offer around 100 specialist presentations in eight conferences. Under the motto users #sharing challenges and solutions in practice, the GMP PharmaCongress & GMP PharmaTechnica Expo once again invite participants to share experiences, discuss and network - at the popular networking event on the first evening.