Over 50% of the top pharmaceutical companies are already using Enzyme Indicators such as Pfizer, Roche, Sanofi, AstraZeneca, GSK, Novo Nordisk for the production of sterile medicinal products.
Protak Scientific are the manufacturer of Enzyme Indicators – the advanced rapid validation tool for measuring hydrogen peroxide bio-decontamination performance.
We’re hosting a webinar to discuss how Enzyme Indicators can help your organisation meet EU GMP Annex 1 compliance.
Date: Wednesday 5 July 2023
(UK & Europe) Time: 1200hrs GMT (1300hrs CET)
European Medicines Agency GMP Annex 1 – the compliance clock is ticking
You’ll be aware of the EU Good Manufacturing Process (GMP) revisions to Annex 1 “Manufacturing of Sterile Medicinal Products” requires compliance provisions to be fulfilled by August 2023.
How does Enzyme Indicator Technology help meet Annex 1 requirements?
Traditionally, any process that uses hydrogen peroxide (H2O2) for decontamination, such as isolators and pass-through chambers, relied on initial validation and periodic revalidation to assess efficacy.
Unlike conventional tools, Enzyme Indicators offer rapid, quantitative feedback in around 60 seconds, per indicator. Due to the speed and quality of data collection, the technology provides a stronger level of confidence in quality assurance and, consequently, a greater data driven and consistent approach to ensure compliance with Annex 1 unlike traditional methods.
Attendance for this webinar is limited so to reserve for you or a colleague please reply no later than Friday 30 June to secure a place.
Please reply to mariapaola.cocco@protakscientific.com
Read about the advantages and benefits of using our Enzyme Indicators for your H₂O₂ bio-decontamination validation processes.
Biological Indicators vs Enzyme Indicators at a glance.
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