Updated guidelines
In August 2022, Annex 1 of the EU GMP guidelines for the manufacture of sterile medicinal products was comprehensively revised.
The new require- ments came into force on 25 August 2023 and aim to improve the sterility and quality of medicinal products. A specific section on freeze-drying and product transfer became mandatory by 25 August 2024.
In August 2022, Annex 1 of the EU GMP guidelines for the manufacture of sterile medicinal products was comprehensively revised
Other guidelines relevant to certain types of aseptic manufacturing have also been updated. For example, the ADKA (Federal Association of German Hospital Pharmacists) is revising its guidelines on the ‘Manufacture and testing of medicinal products in hospital pharmacies’ from 2016 and on the ‘Aseptic manufacture and testing of ready-to-use parenterals’ from 2012.
These updates are intended to meet the increased requirements for quality assurance and improve patient safety.
Technological developments
Technologically, the use of barrier isolators and restricted access barrier systems (RABS) has been established.
These systems provide physical barriers between the product and the operating personnel, significantly reducing the risk of con- tamination. Isolators ensure complete separation of the work area from the environment, while RABS allow controlled but less compartmental- ised access.
In the new Annex 1, isolators and RABs are more or less equated, and corresponding systems are seen as the basic requirement for new authorisation
In the new Annex 1, isolators and RABs are more or less equated, and corresponding systems are seen as the basic requirement for new authorisation. The separation of the aseptic pro- cess from the operator environment is practically mandatory.
New concepts, e.g. automated, gloveless isolators, are increasingly being considered, especially for small batches in the field of cell and gene therapy.
Impact on many levels
The implementation of stricter EU regulations does not only have an impact on technology and the manufacturing process.
At least in the short term, the tightening of Good Manufacturing Practice (GMP) guidelines also led to production bottlenecks in some areas for essential medical solutions such as sterile saline solutions.
The implementation of stricter EU regulations does not only have an impact on technology and the manufacturing process
Many manufacturers were unable to fulfil the increased requirements, which led to supply bottlenecks and delays in medical interventions.
To summarise, current developments in the field of aseptic manufacturing of medicinal products have increased the quality and safety of products, but, on the other hand, have created new challenges for manufacturers and healthcare facilities.
Still, the continuous adaptation to new guidelines and technological innovations remains essential.
Wide range of conference topics at Pharmacongress 2025
The Annex 1 requirements and the associated challenges will also be a topic at the upcoming PharmaCongress 2025 and the accompanying PharmaTechnica Expo in Wiesbaden at the beginning of April.
There, individual conferences will focus on developments in classic areas such as aseptic technologies, isolators and barrier systems through to single-use systems.
Even if RABS and isolators cover the most critical areas, cleanrooms are still far from obsolete. Existing production units with classic A in B cleanroom concepts are still in use in many cases.
A specific conference track will hence concentrate on cleanrooms in ongoing operations and will also deal with the issues of cleanroom materials and their suitability, routine checks, e.g. monitoring and hygiene issues.
The conference will therefore address this topic as well. Experts will highlight the necessary criteria and requirements for the products used
So-called ‘cent’ disposable items in the personnel area such as hoods, gloves, face masks or overshoes – or in the production area – cloths, mop covers as well as associated products such as cleaning agents and disinfectants are often underestimated but important factors in ensuring the quality of the manufactured products.
Incorrect selection or incorrect use can be the source of unwanted contamination with both particles and microorganisms.
The conference will therefore address this topic as well. Experts will highlight the necessary criteria and requirements for the products used.
There is a gap in regulatory guidance in this area, but helpful documents will be presented to provide suggestions and recommendations. In addition, a GMP inspector will explain the expectations from an inspector ’s perspective.
In addition, the congress will also address ‘modern’ topics such as the requirements for ATMPs and cell and gene therapeutics or the quality and safety of medical cannabis
Three further two-days conferences will highlight the industry’s “Pain Points”, i.e. the issues where companies have the greatest difficulties with implementing the Annex 1 requirements in practice, discuss the current state of the art and new technological developments in Barrier Systems and Pharmaceutical Robotics Technology and present the latest developments and possible applications of Single-Use Systems and how to ensure their quality – besides overcoming technical issues.
In addition, the congress will also address ‘modern’ topics such as the requirements for ATMPs and cell and gene therapeutics or the quality and safety of medical cannabis. Further, modern forms of digitalisation such as AI, IOT and Industry 4.0 are playing an increasingly important role in more and more companies. This ranges from risk reduction with ‘digital twins’ and the implementation of robotic isolators to continuous process control with automated trending and reporting programmes.
Thus, to cover the broad spectrum of applications of automation, digitalisation, AI applications and robotics, it will also address digitalisation topics and application of artificial intelligence.
Modern forms of digitalisation such as AI, IOT and Industry 4.0 are playing an increasingly important role in more and more companies
Accordingly, the GMP PharmaCongress 2025 will kick off on April 8, 2025 with a keynote speech on “Artificial Intelligence (AI) in Manufacturing and Quality at Sanofi” by Dr Maite Durrenbach, Chief Quality Officer at Sanofi and responsible for R&D, Industrial Affairs and Commercial Activities.
Altogether, the industry event on 8/9 April 2025 will offer around 100 specialist presentations in eight conferences.
Under the motto users #sharing challenges and solutions in practice, GMP PharmaCongress & GMP PharmaTechnica Expo once again invites participants, attendees, expo visitors and exhibitors to benefit from the wealth of experience of the expert speakers from authorities, industry, and service providers, to exchange ideas and to network at the expo and at the popular social event on the first evening.