The slides that support the webinar presentation ‘An industry perspective on common practise in forced degradation studies of biopharmaceuticals’, presented on 15 June 2021.
Environmental Monitoring in Drug Product (EMinDP)
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Environmental monitoring (EM): Risk assessment template
Feb 2019 | COVID 19, Environmental Monitoring in Drug Product (EMinDP), Fill Finish, POI - Fill Finish
This Excel spreadsheet tool compliments the guidance document ‘Environmental monitoring: harmonized risk-based approach to selecting monitoring points and defining monitoring plans’. This allows the user to assess a room against six factors, the amenability of equipment and surfaces to cleaning and sanitization, personnel presence and flow, material flow, proximity to open product or exposed direct product contact material, the need for interventions/operations and their complexity, frequency of intervention and score them