To help you meet your regulatory obligations, PharmOut offers the following services, specifically for blood and tissue banks and Blood and Tissue Good Manufacturing Practice Regulations.
Our GMP consultants can help you with:
- 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.
- Establishing a robust, cost effective quality management system that will support your GMP compliance aims.
- Troubleshooting and solving specific GMP compliance issues. This may include conducting a pre-audit audit or reviewing the findings from a regulatory audit to determine the best course of action.
Blood and tissue banks are unique in that they must use aseptic processes on non-sterile starting material to preserve it as a low “bioburden” product. This is vastly different to other GMP-regulated industries, such as pharmaceuticals and medical devices and requires a different and more technically challenging approach to ensure compliance and patient safety.
To learn more:
Please contact us to discuss your needs.