Blood & Tissue GMP consultants

To help you meet your regulatory requirements, PharmOut offers the following services, specifically for Blood and Tissue banks.

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 & Tissue banks are unique in that they must use aseptic processes on non-sterile starting material. 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.