The BioPhorum CGT Environmental Health and Safety (EHS) workstream offers this downloadable template for CGT institutions to use to assess and mitigate biosafety risk for human-derived cell lines susceptible to adventitious agents.
risk assessment
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Business continuity management in the biologic industry supply chain: a best practice guide
Mar 2023 | Deliverable, Deliverables Report, POI - Supply Partner, Publication, Supply Partner
This paper and the supporting questionnaire provides best practice guidance for effective business continuity management systems (BCMS) in the biologics supply chain. It can be used in two ways. First, as an introduction to BCMS and second, as guidance to benchmark companies’ current processes. It is based upon the framework in ISO 22301.
Environmental monitoring (EM): Risk assessment template
Feb 2019 | Annex 1, 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