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.
“Annex 16 of the EU GMP Guide requires that documented information on the entire supply chain of the medicinal product is made available to the QP in order for the QP to certify the pharmaceutical product for release to market. Mapping of the supply chain is applicable to the entire supply chain and should include the DS, high and medium risk excipients, intermediates, bulk and finished product transportation, storage and distribution facilities, and associated activities. It should ensure that facilities are licensed appropriately for the activities involved.”