Blood & Tissue Facility Design Review
PharmOut is rapidly developing an enviable reputation in being the premier consultants in designing, building, validating and operating biological, blood and tissue facilities when exacting quality standards are demanded by the nature of the product, we are frequently contacted to conduct blood & tissue – biological facility design reviews or assist in a number of GMP aspects of a blood or tissue banks.
Blood (bovine and human) and tissue manufacturing organisations have deep expert knowledge of their technical processes, but little experience in GMP regulatory compliance, PharmOut can combining regulatory requirements with the deep technical knowledge available on site of blood and tissue processes and assist in making safer therapeutic goods.
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.
Our Blood & Tissue Facility Design Review Services
PharmOut provides Blood & Tissue facility design review services by our pharmaceutical architects, engineers or GMP consultants ensure compliance with blood and tissue banks requirements – by 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, alternatively our architects and engineers can assist in the design, construction, validation and operation of these facilities. PharmOut has worked on a number of projects in Canada, China, New Zealand, South Africa and of course many in Australia. Generally we design to the US FDA, EU GMP or the PIC/S GMP regulations.
To learn more:
Please contact us at one of our offices around the world to discuss your needs.
