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New third-party audit scheme for excipient suppliers

22 October 2015  •  Author(s): Iain Moore, President, EXCiPACT asbl

There has always been a regulatory requirement for pharmaceutical manufacturers to audit their starting material suppliers, but the expectations are even clearer now that these audits, including those for excipients, have to be in vivo. With increasing requirements for physical audits, can all pharmaceutical companies address the number of audits within a realistic frequency? Equally, suppliers of excipients to their many pharmaceutical customers face an avalanche of audits. With both sides having limited resources is there a third-party audit solution which meets regulatory expectations and is efficient in resources?

New third-party audit scheme for excipient suppliers

In Europe, the Falsified Medicines Directive (FMD) was developed as a result of product failures in legitimate supply chains in the early 2000s and had the objective of ensuring the availability of high quality and safe medicines. Although many of the falsified medicines have involved final dosage forms, starting materials have also been impacted, notably with sub-standard active pharmaceutical ingredients (APIs) and some excipients entering the supply chain. The notorious and tragic incidents involving ethylene glycol substitution for glycerine and then adulterated Heparin resulted in hundreds of patient deaths.

The FMD introduced the legal definition of a pharmaceutical excipient for the first time as being: “any constituent of a medicinal product other than the active substance and the packaging material”. It also requires that the manufacturer ensures the excipients are suitable for use through the adoption of a risk assessment approach to determine the required good manufacturing practices (GMP) for the manufacture of the excipient.

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