EXCiPACTTM: Minimize risks, maximize benefits
The safety of medicines for patients is paramount to all: the pharmaceutical industry, suppliers of excipients, national and regional health care agencies and regulators. To assure the quality of medicines produced, risks in the supply chain need to be evaluated and minimized.
Thousands of different excipients are used in medicines and make up, on average, about 90% of the volume or weight of each product. They represent a market value of approximately €3 billion, accounting for 0.5% of the total pharmaceutical market according to industry experts. However, few excipients are manufactured solely for pharmaceutical use.
With legislation requiring cGMP and cGDP for excipients in Europe and the USA, excipient suppliers will be faced with an avalanche of quality audits and related requests to ensure their facilities and products meet these new requirements. Legislation for the USA already exists, it’s a matter of implementation. It can be argued that the Falsified Medicines Directive means “legislation” for Europe on these matters too.
Excipient suppliers, distributors and the pharmaceutical industry are fully committed to control the use of high quality excipients throughout the supply chain, and ensure this by self-regulation. As a result, a group of industry experts from the European Fine Chemicals Group (EFCG), the International Pharmaceuticals Excipients Council (IPEC) Europe, IPEC Americas, the European Association of Chemicals Distributors (FECC), and the Pharmaceutical Quality Group (PQG), have worked together on the development of a certification scheme for pharmaceutical excipient suppliers – called EXCiPACTTM.
All these parties are in agreement that an international pharmaceutical excipient current good manufacturing practice (cGMP) and current good distribution practice (cGDP) certification scheme is one of the tools which will help to ensure the quality and reliability of these key ingredients for medicinal products throughout the supply chain.