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- Title
Risk-based environmental control and process monitoring in aseptic processing.
- Authors
Drinkwater, James L.; Van Laere, Marc
- Abstract
Risk-based environmental control, delivered by technical and organisational good manufacturing practice (GMP) control measures, are inherently linked to risk-based environmental monitoring (EM) and trend data analysis. Process monitoring is reported as a developing requirement in the revision of the EU Guidelines to Good Manufacturing Practice Annex 1 which combines all EM programs through classification/characterisation, media fills/process simulations, routine EM and batch/shift end surface sampling as one plan. This article considers the control measures for environmental control in different aseptically processed product types together with requirements in risk-based EM.
- Subjects
ASEPTIC packaging; ENVIRONMENTAL engineering; PROCESS control systems; CURRENT good manufacturing practices; DATA analysis; BATCH processing
- Publication
European Journal of Parenteral & Pharmaceutical Sciences, 2015, Vol 20, Issue 4, p133
- ISSN
1740-6277
- Publication type
Article