The risks to product quality in an increasingly globalized supply chain – a prime driver of the CMC and GMP agendas of regulatory agencies – are also pushing pharmacopeias around the world to speed up their efforts to harmonize and modernize the compendial standards that support these regulatory processes.
At issue are the relatively slow-moving pharmacopeial harmonization efforts that are not keeping pace with the regulatory agency needs for updated specifications to detect and counter the supply chain threats. There is an increasing recognition of the pressing need for global, scientifically current monographs for a global supply chain.
At the IPEC ExcipientFest conference in late April in Raleigh, North Carolina, USP Excipients Senior Director Catherine Sheehan explored the impact the global supply chain is having on pharmacopeial harmonization and modernization and how the progress on these two efforts are interconnected.
“The risks associated with the global supply chain have led to the need for quality compendial specifications that are both harmonized and modernized,” she emphasized. Global specifications “will provide a much needed regulatory tool to qualify an excipient for its intended purpose.”
In USP’s case, some existing excipient monographs “migrated in from 1880 from the original National Formulary, and they have yet to be modernized,” she said. “We are sometimes dealing with 17th and 18th century analytics…. A smell test does not cut it in today’s global supply chain.”
In her presentation at the IPEC meeting, which was focused heavily on excipients, Sheehan discussed: ● USP quality standards and the law ● the role of the Pharmacopeial Discussion Group (PDG) ● the benefits and challenges of harmonization ● USP’s modernization initiative and strategies, and ● modernization efforts by other pharmacopeias. [Editor’s Note: Sheehan’s complete remarks are included below.]