In Europe no batch of medicinal product can be released for sale or supply prior to certification by a Qualified Person (QP) who is named on an MIA (Manufacturer’s/Importation Authorisation).
When a company contracts MIAS for a clinical trial or commercial batch certification, one of our first steps is to evaluate the GMP/GDP compliance status of each of the parties in the supply chain, from API manufacture through to transportation. Typically, this is done through what we term a ‘QP Audit’. These Audits may be performed by our QPs or by experienced auditors who have been approved by our QPs. When satisfactory compliance has been confirmed, we vary the relevant MIAS Pharma MIA to add your drug product and all relevant 3rd parties in the supply chain.
If you have an upcoming audit or would like to support our oversight and qualification of your suppliers, we have a European wide panel to support your project. Please contact us for more information.