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Focus on excipient quality: evolving regulations require a fresh approach


Editorial Consultant, EXCiPACT™


Pharmaceutical manufacturers are facing increased regulatory demands to ensure that the raw materials that go into their medicines – including excipients – are safe, high -quality and sourced from reputable suppliers. The recently launched certification scheme EXCiPACT™ is fast emerging as an ideal tool to help meet these evolving requirements.

The last couple of years could be regarded as something of a watershed period for the pharmaceutical industry from a regulatory perspective, as new regulatory requirements are introduced around the world to make sure patients receive medicines that are safe and of high quality.

That heightened focus has been prompted by incidents in which falsified medicines have infiltrated the supply chains of even relatively secure markets such as Europe and the US, as well cases where adulterated pharmaceutical ingredients - both active and inactive - have found their way into medicines and exposed patients to harm (1, 2).

Many of these incidents have involved finished products and active pharmaceutical ingredients (APIs), such as the notorious case involving contaminated heparin a few years ago, but even excipients have been known to cause serious problems. In 2008, for example, at least 84 children died as a result of deliberate substitution of the widely-used excipient glycerine with diethylene glycol (DEG) in a teething mixture, just year after a similar case involving a cough mixture killed 21 people in Panama.

Thankfully, these incidents are rare, but with threa ...