Most recent debate surrounding the Falsified Medicines Directive (FMD) has focused on how import requirements introduced on July 2 will impact drugmakers trying to bring APIs into the European Union.
But the scope of the FMD is extends beyond APIs. Excipients – the other key ‘ingredients’ in the drug production process - are also covered by the 2011 legislation with drugmakers being required to ensure they are suitable through formalized risk assessments.
Similarly, China recently cracked down on ‘high risk’ excipients and placed most of the burden of responsibility for ensuring quality on drugmakers.
With this in mind we asked Dr R Christian Morton of US-based FinnBrit Consulting how good the drug industry is at monitoring excipient quality. And the news isn’t good, particularly for drugmakers in the US.
He told in-Pharmatechnologist.com: “The qualification of excipients and excipient supply is patchy. Some companies do a very good job, some do a very poor job in my opinion.
“The logistics are such that it is not possible for all users of a major excipient to audit the manufacturing site within a two- or three-year time period,” Moreton continued, adding that “there just are not enough days available.”
Moreton also suggested that another factor in his assessment is US drugmakers' failure to embrace measures put in place by regulators.
“The FDA has said that third-party audit and certification schemes can be acceptable with certain safeguards, but excipient users [pharmaceutical product manufacturers] seem reluctant to adopt them.”
Some pharmaceutical firms have instead used paper questionnaires to assess quality according to Moreton who said: “This is potentially a disaster waiting to happen, particularly with some overseas excipient manufacturing sites. In my opinion, questionnaires are useful as a preparation tool for an audit, but nothing more.”
“I think there needs to be a change in the quality culture in the US. At the moment, it seems to me that there is an attitude in some parts of the pharmaceutical industry of “let’s do the minimum we can get away with” rather than “let’s make sure that the patient is not exposed to unacceptable risk from our products.”
To QP or not to QP?
In the EU drugmakers are required to employ a qualified person who must - by law - make sure finished drug products destined for clinical trials or pharmacy shelves are of an appropriate standard. Those failing to do so risk losing this professional status.
But despite his calls for US drugmakers to do more, Moreton is not convinced the QP scheme would work on the other side of the Atlantic.
“The QP concept is not perfect, but I have not seen anything better. However, I do not think the QP concept will work in the US because of the litigious nature of our society, but we do need to do something to improve the standards as a whole and this obviously includes excipients.”