EU GMP Annex 1 is driving the reevaluation of key processes in aseptic processing. For manufacturers, this means that existing plant designs, setup procedures, and operations within isolators must be reviewed for regulatory compliance and realigned, as well as assessed and documented as part of a Co…

– Special Truck travels to customer sites across Europe until April 2027
– Live demonstrations of automated contamination control technologies
– Practical support for Annex 1 compliance – from initial assessment to lifecycle services

Syntegon, a strategic lifecycle partner for the pharmaceutical, biote…

What is continuous environmental monitoring under EU GMP Annex 1?

Under EU GMP Annex 1, continuous monitoring must be maintained for the full duration of critical processing, positioned to avoid disrupting first air protection, using qualified systems capable of real-time detection of excursions.

Anne…

Monitoring systems should no longer only trigger alarms; they must actively recognize trends and provide traceable reports. Learn how targeted data analysis and statistical methods can reveal hidden risks and future-proof your quality strategy in the following article.

With the revision of EU-GMP Ann…

Sterile medicines and medical devices must be packaged contamination-free; the requirements for sterilization of components are regulated by the EU-GMP guideline. The sterilization obligation, with the updated Annex 1, since the end of August 2024, applies not only to directly and indirectly product…

Cleanroom operators today collect a multitude of quality-related data: continuous particle measurements in critical areas, temperature and humidity data, differential pressures, microbiological findings, results from mobile measurements, laboratory information from LIMS systems, as well as status an…

Trending in GMP Annex 1 – From "Nice-to-have" to Regulatory Requirement

With the revision of EU GMP Annex 1 in 2022, the regulatory environment for the manufacturing of sterile medicines has fundamentally changed. A central element of this revision is the mandatory introduction of systematic trending…

Similasan AG develops and manufactures homeopathic medicines. The company, based in Jonen in the canton of Aargau, employs around 100 people in Switzerland. Its product range includes more than 110 homeopathic preparations approved by Swissmedic. Similasan is the world's largest manufacturer of natu…

The hygiene requirements for the industrial production of pharmaceuticals, food, and cosmetic products are continuously increasing. Globalization and the widespread distribution of products for humans and animals can have worldwide impacts in case of emergencies. Although all three sectors have diff…

The month of March was particularly busy for AM, with a strong presence at international trade shows and events. These included the Lounges 2025 stood out as a valuable opportunity to present innovative solutions in the pharmaceutical secondary packaging sector. Elena Mantegazza, Product Specialist…