Navigating Emerging Contaminants: Annex 1 & Contamination Control

Navigating Emerging Contaminants: Annex 1 & Contamination Control

Wednesday, October 29, 2025 4:00 PM to 4:15 PM · 15 min. (Africa/Abidjan)
Hall 12.1 - 12.1C68
Future of Pharma & Ingredients
Formulation

Information

Overview: EU GMP Annex 1 - Manufacture of Sterile Medicinal Products.


Relevance: Emphasis on Contamination Control Strategy (CCS) aligning with efforts to control Nitrosamines, PFAS, and other impurities.


Implementation: Risk-based approach, monitoring systems, holistic mitigation strategies.

Siegfried AGSiegfried is a preferred partner for complete integrated Drug Substance and Drug Product services with production capabilities worldwide. Creating, improving and manufacturing formulations is our passion. Our professionalism is pivotal for your project throughout the entire life cycle. Our offering, the combination of inherited technical know-how and expertise, is unique for a supplier of development and manufacturing services. Our Drug Substance services include Custom Development and Contract Manufacturing for both APIs and intermediates. In addition, we offer a multiclient API portfolio (including controlled substances) with drug master files and patented technologies. Our Drug Product clients benefit from a broad spectrum of dosage forms and technologies like oral solids, inhalative products, opthalmics and sterile ointments. Drug Product services include Custom Development and Contract Manufacturing for the dosage forms mentioned above. Siegfried enhanced its Drug Product capabilities with the acquisition of two Novartis sites near Barcelona and the establishment of a center of excellence for developing and optimizing formulations. Thus, we expanded our competency with high potent Drug Product development and manufacturing down to an OEL of 1Mug/m3, next to capsules with APIs (down to 0.1 Mug/m3). Complex oral drug delivery systems or solubility increasing of APIs (e.g. nanomilling or spray drying) belong to our core competences. In the field of steriles, we are experienced with fill and finish of vaccines and biologic compounds. Furthermore, we can offer dry powder inhalator capsules. Siegfried has 11 GMP approved sites worldwide spanning both the eastern and western hemispheres. Our Drug Substance sites are located in Zofingen (Switzerland), Pennsville (US), Nantong (China), Minden (Germany), Evionnaz (Switzerland) and St. Vulbas (France). Our Drug Product locations are in H...

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