IPEC Americas takes aim at atypical visible particles
pharmafile | March 4, 2013 | News story | Manufacturing and Production | AVP, IPEC Americas
The industry body representing excipient users and suppliers in the US has set up a working group to tackle the thorny issue of atypical visible particles, which have led to a number of recalls in the last couple of years.
IPEC Americas’ Excipient Composition Committee has set up the working group – which is headed by Dow Chemical’s Ann Van Meter – to develop guidance that will help assess the significance of AVPs, which are typically seen as discoloured spots on tablets and other pharmaceutical formulations.
“AVPs continue to be contentious”, said IPEC Americas, which notes that AVPs have always been present, and may even be intrinsic to the excipient.
One possible source is charring of white-powder excipients during the drying process for tablets, and the problem is thought to be a particular issue for polymer-based excipients that can be prone to discoloration.
FDA has issued several Form 483s to pharmaceutical manufacturers for insufficient or incomplete investigations of AVPs, and there are concerns that a zero-tolerance approach by regulators could be unachievable by firms.
The consequences could be materials being rejected without due cause, while drugmakers could waste time, money and resources investing AVPs that pose no risk to patient safety.
“The natural reaction to this increased compliance burden is to decree that AVPs be absent but this may not be technically feasible,” according to IPEC Americas, which noted that previous guidance from IPEC, the US Pharmacopeial Convention (USP) and the FDA does not address the issue.
Pharmaceutical excipients are disadvantaged relative to food ingredients in this regard by the absence of de minimis standards, it added.
The Excipient Composition Committee met last week (26 February) at IPEC-Americas’ new headquarters in Arlington, Virginia, to discuss the issue.
Phil Taylor
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