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Jahresbericht 2010 der ISPE-Filiale Deutschland / Österreich / Schweiz rCoP „PAT“ ff � PAT CoP D/A/CH ist mit Co-Chair in ISPE PAT Steering Committee international vertreten � In 2007 Erstellung des Dokumentes „Creating QbD/PAT Management awareness“ � Derzeitige Aktivitäten: Greenfield Study „Pharma 2020“, mit Fokus auf das Thema „QbD/PAT Implementation for future lean manufacturing“ (kick-off workshop im Nov. 2008 in Säckingen) � The “Greenfield Study” provides an innovation and knowledge platform collecting state-of-the-art techniques, methods and visions regarding safe and lean pharmaceutical processing. � The PAT CoP D/A/CH is open for pharmaceutical industry, suppliers, research organisations, authorities and service providers covering the whole drug life cycle. � The meetings focus on practical solutions for distinct applications in Pharma & Biotech manufacturing and quality control. � The meetings are focused on practical solutions for distinct applications in Pharma & Biotech manufacture and quality control. Werner Oesterle, 31. März 2011 Seite 16
Jahresbericht 2010 der ISPE-Filiale Deutschland / Österreich / Schweiz rCoP „PAT“ ff: PAT CoP DACH Meeting Oct. 2010 Short description of the event: The actual activity of the CoP “Greenfield Study – Pharma Vision 2020 for future lean pharmaceutical manufacturing” was again the state-of-the-art platform for the focus topic of the 15 th meeting at Novartis headquarters, Basle Switzerland: “Optimized fermentation processes. QbD – a vision shared”. During the 2-day meeting course 7 presentations from suppliers, companies and solution providers were held on fermenter design & disposables, fermentation process control systems, optimisation projects by PAT applications, data management, and latest FDA news on biologics license applications and authorities’ expectations. What is the key benefit of our event, initiative, or other?: The “Greenfield Study” offers a platform for innovation in pharmaceutical development, manufacturing and quality control. QbD and PAT tools have been practically discussed within the regulatory framework of FDA´s PAT guidance and ICH Q8-Q11 guidelines. The sessions are backed by a strong life cycle management view and are focusing mainly on future lean processing for APIs and finished drugs (oral solid dosage forms & biologicals). Werner Oesterle, 31. März 2011 Seite 17
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