Validation Planning and Design Review for Biologics R&D Pilot Facility
IPS provided Validation Planning and Design Review expertise for the design of a new biologics R&D Pilot Facility in Israel. IPS ensured the design met FDA and EMEA regulatory requirements and cGMP via our risk-based validation approach. The IPS team developed a site Validation Master Plan which detailed the overall approach to specification, design, construction, commissioning and qualification of the new facility.
- Provided the flexibility and the manpower to meet the project's aggressive timeline
- Worked with the Design Firm to complete the BOD and develop a template for User Requirements
- Established Design Review procedures and forms
- Performed cGMP reviews on the equipment design packages
- Established a risk-based approach to specification, design, construction, commissioning and qualification
- Provided access to vast biotech expertise required for biotech-specific validation activities
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