CRED Getting the CMC Dossier Right 2024

28/08/2024

What is a Pharmacopoeia? (1)

• Authoritative collection of standards, published under official sanction by a government or other body • Constantly updated to reflect ‘state -of-the- art’

• Strength and purity standards for therapeutic drugs • Active substances, individual and general • Medicinal products, individual and general • Raw materials, inactive ingredients • Packaging materials, containers and closures • Analytical tests • Certain manufacturing process, such as sterilization • Unlicensed medicines

Official Reference Standards

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What is a Pharmacopoeia (2)

• Important part of the quality framework for medicines • Monographs are shelf-life standards • Legal status in source country as well as other countries/regions •

USP/NF | FD&C Act “Official Compendium” with respect to adulteration and misbranding • BP | The Human Medicines Regulations 2012 “Specified Publication” for product compliance • BP | Irish “Saorstát Eireann Pharmacopoeia” • BP is “national pharmacopoeia of a Member State” per Annex 1, Dir 2001/83/EC • Ph. Eur. compliance is established by the Convention on the Elaboration of a European Pharmacopoeia, Protocol to the Convention (#134), Dir 2001/83/EC and Dir 2001/82/EC • JP is an “Official Standard” by MHLW for proper properties and quality of pharmaceuticals

• Regulatory and enforcement action for non-compliance with pharmacopoeia

The Organisation for Professionals in Regulatory Affairs

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