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Third-Party Stand-Alone C&Q for Sterile Vaccine Manufacturing Facility

We commissioned and qualified a sterile vaccine manufacturing facility and developed a Comparability Protocol (CP) for validation testing strategy and scientific rational of the validation program in the insulin manufacturing suite, all within a 90-day shutdown period.  The client purchased new equipment to meet regulatory expectations and general upgrades. IPS conducted a review of pertinent documentation, including procedures, plans and executed protocols, then developed the testing requirements for each system to be considered validated, as well as a rational for the testing location.

The equipment was qualified in two phases, the first phase challenged the equipment at a remote location and the latter phase challenged the equipment in the final production facility through a reduced test approach. The commissioning team worked closely with the construction manager and sub-contractors to verify the system operation was mapped and matched the owner’s requirements.