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Context
Biological risk assessment is a basic requirement of all biosafety regulations and the cornerstone of sound biorisk management.
Biosafety regulations most generally require a documented risk assessment as part of the authorisation process. The risk assessment consists in identifying the hazards that the biological agents or materials in use may present and assessing the risks linked to the running of the operations and activities. The analysis has to be carried out in perspective of possible effects on both the health and the environment. Risk assessment has to be prolonged as a continuous process as operations go on, for instance at the light of new information or in case of process modifications. This is part of the review process implied in biorisk management systems.
Hazard identification can be quite straightforward for well-known pathogens or other organisms but may become much more complex when genetically modified organisms (GMOs) or atypical agents (such as opportunistic or emerging strains for instance), materials or cell lines are concerned.
Assessing the operational risks require looking at all aspects of the operations, starting from their overall purpose ("contained use" or "deliberate release" in the European regulations). The type of activities, the concentration of hazardous materials, the scale of work, the characteristics of the environment, the protective measures, the risk of human or technical failures and many other aspects should be evaluated for the whole process.
Services
We are ready to provide assistance in biological risk assessment in the following ways:
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- carry out documented hazard identification and risk assessments as part of our regulatory support activities
- realise technical risk assessments of specific equipment, activities or operations
- set up a methodic risk evaluation approach and define customised risk assessment procedures.
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The auditing services we propose are also risk-based. They take into consideration the risks of the operations for the personnel, the community and the environment, but also the possible impact of non-compliance events, incidents or accidents on the company or institution.
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