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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.