The design of the ‘Biopharma Quality Engineering Data Management’ program in the Avenio engine facilitates the portrayal of plant processes in producing safe, pure and efficacious products. The process streams are supported by plant, facilities and systems whose attributes are all individually risk assessed by virtue of their inclusion based on the principles highlighted in ASTM E2500. However this does not in itself guarantee a low risk process as process steps in themselves are interlinked, often interdependent and subject to both individual and collective risk.
As an example a bioreactor as an entity may be designed and engineered to function in accordance with its associated specifications but may be operated incorrectly or fed by a system that in itself was operated incorrectly etc.
As such the process as an entity must be risk assessed, controlled and reviewed using the quality risk management principles defined in ICH Q9. Avenio therefore becomes a vital tool as a risk communication/mitigation vehicle, when used as a system for maintaining and updating process data supplied by process, plant and quality subject matter experts.
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