Video: The EU Annex 1 Good Manufacturing Process (GMP) updated requirements
Posted: 11 July 2023 | Protak Scientific Limited | No comments yet
How the GMP requirements affect the manufacturing of sterile medicinal products from European Member States and products imported from outside Europe.
Protak Scientific manufacture ‘Enzyme Indicators’ – the advanced rapid validation tool for measuring hydrogen peroxide bio-decontamination performance that’s transforming the validation process in pharmaceutical manufacturing and other applications including healthcare and research.
We supply, project manage and support over 50% of the top twenty largest pharmaceutical companies and manufacturers of equipment including Pfizer, Roche, Sanofi, AstraZeneca, GSK, Novo Nordisk and manufacturers of equipment used during the production of sterile medicinal product and medical devices.
Kate Marshall, Protak Scientific’s Technical Director shows how Enzyme Indicator technology meets the challenges of EU GMP Annex 1.
Her presentation highlights how Enzyme Indicators provide increasing assurance in H202 bio-decontamination cycle efficacy. She highlighted the processes that utilise Hydrogen Peroxide (H2O2) for decontamination (e.g. Isolators, pass-through chambers, room decontamination, etc.) – which have traditionally relied on initial validation and periodic revalidation to check the efficacy of the process with biological indicators (BIs).
Related topics
Analytical techniques, Biologics, Biopharmaceuticals, Bioprocessing, Data integrity, Good Manufacturing Practice (GMP), Lab Automation, Manufacturing, Medical Devices, Microbiology, Outsourcing, QA/QC, Research & Development (R&D)
