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 Batch Release a drug product (Batch Disposition) the QP is required to be on a licence known as an MIA (Manufacturer’s/ Importation Authorisation). In 90% of cases our clients then opt to go the Contract MIAS QP route (Pay As You Go model) rather that recruiting their own personnel for Batch Release. However, if a client does have their own QP the option is available to add them to the relevant MIAS MIA for Batch Disposition to occur.
Pharmaceutical supply chains often extend across multiple transportation routes and regulatory jurisdictions. Without Supply Chain Oversight these complex supply chains present challenges in terms of maintaining quality of medicinal product in-transit and the increasing global risk of Falsified Medicines entering the supply chain.
The EU currently consists of 28-Member States; each has its own market nuances for transportation and distribution of pharmaceutical materials that will need to be addressed. There is significant complexity to navigate in determining a commercialisation strategy for the EU, supply chain mapping and optimisation of the supply chain structure to facilitate GxP compliance can deliver significant financial savings over the life cycle of a product.