PIC/S, the EMA, the US FDA and the Australian TGA all publish regulations that govern human blood and tissue banks and processing plants. The challenge for individual companies then, is to navigate through this regulatory milieu so that they are in compliance with their region’s applicable codes of Good Manufacturing Practice (GMP) (and others depending on the range of their business!).
PharmOut has extensive experience in this field and can help you meet the regulatory requirements. We have a demonstrable and proven track record in offering and delivering the following services – from the initial design and build of your facility to the validation and operation of Blood and Tissue banks, Biological manufacturing plants and clean rooms:
PharmOut can provide experienced Biologicals, Blood And Tissue GMP Consultants to help you navigate through all the regulatory requirements for the manufacture and processing of Biologicals.
To prepare for an official regulatory audit, it’s wise to have a pre-audit performed by one our consultants to check the GMP ‘health’ of your facility. This way you can find and address any problems you might have well in advance.
If you’ve got a huge project looming in the distance and don’t know where to begin, we also offer project management services to help you get production up and running as well as complying with the relevant regulations.
PharmOut has a large collection of online training modules and offers a variety of training options to suit your needs in the form of public courses, eLearning and on-site.
If you’re short on staff or resource-poor, we can help you find temporary or permanent staff with the specific technical skills and experience that you require to move forward.
PharmOut offers a range of services and products aimed at delivering a QMS compliant to ICH Q10 for Blood and Tissue banks.