PIC/S, the EMA, the US FDA and the Australian TGA all publish regulations that regulate human blood and tissue banks, that must comply with the appropriate Good Manufacturing Practice (GMP) codes.
To help you meet your regulatory requirements, PharmOut offers the following services, specifically for Blood and Tissue banks.
PharmOut's consultants know how to successfully combine the unique requirements of blood & tissue processing with the GMP regulations for the regions the final product is supplied to. More
PharmOut offers a range of services and products aimed at delivering a QMS compliant to ICH Q10 for Blood & Tissue banks. More
If you are building a new Blood & Tissue facility or refurbishing an old one, it's important to have the plans reviewed to ensure that they meet current GMP requirements. More
We offer project management services for all plant upgrades and compliance remediation projects.
If you need validation resources to support a project, we have experienced professionals to help you. More
If you have a regulatory audit coming up, make sure you are ready by having a pre-audit by one of our experienced consultants.More
We offer a wide range of GMP, validation, risk management and QMS training courses. More
If you need GMP-knowledgable staff for Quality roles within a Blood or Tissue bank, we have an extensive network of candidates. More
PharmOut consultant, Ashley, describes the issues of combining GMP requirements with the operational requirements of a tissue bank.