GMP risk based environmental control and process monitoring for aseptic processing
Maschinen- und Anlagenbau
Key Words risk based | environmental monitoring | aseptic processing | trend metrics
Abstract
Manufacture of sterile medicinal and therapeutic products requires an approach following risk based initiatives and Good Manufacturing Practice (GMP). Quality Risk Management (QRM) is a principle regulatory requirement based on designing the process properly, understanding where the weaknesses are, proceeding to explore those weaknesses and applying appropriate control measures (technical and organisational) to reduce risks to low and manageable levels.
In principle this is relatively straight forward; understand the process, including critical quality attributes (CQAs), and by doing so understand the risks to product quality and patient safety in sterile product manufacturing. With risks understood control measures and deviation detection can be applied.
As straight forward as these principles seem, firms find difficulty to meet risk based GMP expectations with tangible process solutions. This article considers some principles of risk based environmental control and monitoring to help apply risk control measures and environmental monitoring methods that meet best practice requirements.
Korrespondenz:
James L. Drinkwater, Head of Aseptic processing technologies and GMP compliance, Franz Ziel GmbH, Josef-Suwelack-Str. 20, 48727 Billerbeck; e-mail: James.Drinkwater@ziel-gmbh.com
 | James L. Drinkwater James L. Drinkwater is Head of Aseptic processing Technologies and GMP Compliance at Franz Ziel GmbH and works in the area of aseptic processing specialising in separation barrier technology, isolators and Restricted Access Barrier systems (RABS) and associated material transfer devices. As Chairman of the Pharmaceutical and Healthcare Sciences Society (PHSS), a not-for-profit society, he is involved in GMP |
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