Integration of Biosafety in GMP CGT facilities
This workstream aims to assess the misalignment between biosafety containment and GMP requirements in CGT facility design.
Some CGT facilities meet GMP requirements but not do not fully ahere to current biosafety containment guidelines
A current challenge in the field of cell and gene therapy and RNA (CGT and RNA) facility design lies in the misalignment between good manufacturing practice (GMP) requirements and biosafety containment guidelines.
This misalignment often results in facilities that do not fully adhere to biosafety guidelines, such as inadequate access to essential safety features like eye washes and hand-washing sinks, and improper management of inward airflow. The lack of industry alignment on marrying GMP requirements with biosafety containment guidelines hinders the seamless integration of these critical aspects into facility design.
Site will be built 'right first time', with improved operator safety
The proposed solution aims to address these challenges by establishing industry alignment on the integration of GMP requirements and biosafety containment guidelines with CGT and RNA facility design.
By demystifying and normalizing peer-reviewed EHS principles and incorporating them into the design process from the outset, this solution seeks to mitigate regulatory compliance gaps and reduce risks to personnel. It also enables proactive measures to be taken, rather than relying on reactive responses to process breakdowns or the imposition of fines before engaging EHS resources.
Integration of Biosafety in GMP CGT facilities deliverables
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