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.

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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…

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…

With the implementation of the EU GMP Annex 1 ("Manufacture of Sterile Medicinal Products"), pharmaceutical companies are facing new challenges, particularly in the fill-and-finish processes—the filling and final processing of medicinal products. Annex 1 introduces expanded requirements for the oper…

The implementation of EU GMP Annex 1, which sets strict requirements for the production of sterile medicines, presents new challenges for pharmaceutical companies. In the foreseeable future, Ralf Wagner, Sales Director for the DACH region, Portugal and Spain at Optima Pharma, believes that glove int…