Blood & Tissue GMP Consultants
Blood and tissue banks provide unique challenges in that they rely heavily on the use of aseptic processing to create a low “bioburden” product out of non-sterile starting material. This is vastly different to other GMP-regulated industries, such as pharmaceuticals and medical devices – and there is an additional complication: the biological material that is derived from the blood and tissue processes is not able to be terminally sterilised as the process would destroy the actual products. In the Blood and Tissue industry it is even more critical than ever to ‘build-in’ quality at every step of a manufacturing process in order to ensure compliance is achieved and there is minimal residual risk to the patient.
Our GMP consultants can help you:
- Determine which vendors are appropriate to use. Vendor assurance is often stricter than in other disciplines – to ensure the bioburden levels remain within acceptable specifications, a lot of emphasis is placed on the materials and reagents used to process the starting material into its final form.
- Determine which GMP codes you need to comply with based on where final product is supplied to. PIC/S, the EMA, the US FDA and the Australian TGA all publish regulations that regulate human blood and tissue banks and one or many might apply to your operations depending on the breadth of your operations.
- Establish a robust, cost effective quality management system that will support your GMP compliance aims. For products derived from and for humans, control and traceability are key to ensuring compliance with the relevant regulatory requirements.
- Troubleshoot and solve specific GMP compliance issues. This may include conducting a pre-audit to ensure that your site is audit-ready or, if you’ve already had an audit, we can help with reviewing the findings from a regulatory audit to determine the best course of action.
Please contact us to discuss your needs.