The relationships and the communication gaps between ingredient producers, distributors, dosage form manufacturers and regulators when atypical actives are involved received a public airing at a workshop cosponsored by PDA and FDA in March in Bethesda, Maryland.
The workshop brought together the players involved to develop a clearer understanding of the issues raised and a road map of how to address them when ingredients commonly used as excipients take on the role of an active ingredient in the dosage form.
A primary issue is the applicability of the API GMP requirements provided in ICH Q7 in the atypical active context.
Excipients may be manufactured with quality standards suitable for their intended use without complying with Q7, and the International Pharmaceutical Excipients Council (IPEC) has produced a significant body of well-accepted guidance on what is needed in the excipient context and how the requirements differ. In turn, a move to apply the API GMPs more strictly to excipients when they are used in the atypical actives context could be disruptive to the supply chain for these primarily OTC products and create unnecessary burdens for all parties involved.
In her opening remarks, meeting co-chair Janeen Skutnik-Wilkinson, who is a director of quality strategy at Pfizer, pointed out that the workshop was “the first…anywhere in the world” that has focused on the issues arising from atypical actives.
She stressed that the participants in the chain must all work together to understand and address the challenges posed by the uncertain regulatory expectations and a lack of communication between the players.
[An analysis of the workshop discussions on the current challenges that atypical actives present for supply chain participants and regulators is provided for subscribers here. See the IPQ “In the News” March 21 companion story for the recommendations that emerged from the PDA/FDA workshop. Non-subscribers can purchase the stories for $95 each by contacting Peter Blachly (Peter@ipq.org). For subscription/license information click here.]