In Europe no batch of medicinal product can be released for sale or supply prior to certification by a Qualified Person (QP). For a QP to certify a batch of a drug product the QP is required to be named on a licence known as an MIA (Manufacturer’s/ Importation Authorisation).
When a company contract MIAS be it for a clinical trial or commercial release, our first step is to name their drug product on the relevant MIAS MIA. In 90% of cases our clients opt to use MIAS QPs (so-called Contract MIAS QP route (Pay As You Go model) rather than recruiting their own personnel for Batch Certification. However, if a client does have their own QP the option is available to name them on the relevant MIAS MIA.
Should a client go the Contract QP Route the MIAS QP will first require training on the client’s product, processes and Pharmaceutical Quality System, including the interactions with third party Quality Systems. This is often carried out on-site or as appropriate and will include preparation for batch release activities.