Services

 

Blood & Tissue Facility Design Review

Combining regulatory requirements with blood and tissue processes

Typically, blood and tissue organisations have expert knowledge of their technical processes, but little experience in GMP regulatory compliance.

If the organisation is government-operated they are usually required to put facility design and construction out to tender. This sometimes results in the facility design being awarded to a contractor with little or no GMP experience. If there is little GMP knowledge within the blood & tissue organisation itself, then using a third party with GMP expertise to review the facility design is critical.

PharmOut provides facility design review services to blood and tissue banks - applying our GMP and aseptic processing knowledge to this unique environment. We review the facility design plans from a GMP compliance perspective, suggesting changes before building begins. This can save having to spend a lot of money on remediation work later on - when a regulatory auditor comes to visit.

After reviewing the plans, we'll send you a report, detailing our findings and suggestions. If you'd like us to meet with your architects or builders to go through what we've found then we can do that too.

To learn more:

Please contact us to discuss your needs.