Getting involved with pharma standards

Pharmaceutical Technology reached out to the US Pharmacopeial Convention (USP) to get an understanding about how pharma manufacturers can get involved in developing industry standards.

PharmTech: How can pharma companies work with USP to help develop standards and monographs?

USP: Pharmaceutical companies can work with USP in the following ways to participate in the development of standards and monographs:

• Donations: Companies can donate product specifications, analytical methods, and other procedures to help advance the development and revision of USP standards. Companies also can donate bulk materials as candidates for the development of physical reference standards.

• Volunteering: Industry experts are invited to apply to participate in the decision-making and advisory bodies that set USP standards.

• Feedback: Industry is encouraged to review and provide comments on proposed standards revisions via Pharmacopeial Forum, as well as participate in USP Workshops, Stakeholder Forums, and other events.

PharmTech: Are there USP programs addressing health crises or unmet needs with which companies can get involved?

USP: USP advocates for quality standards around the world. We work through global partnerships, regional networks, and capacity-building programs to help regulators strengthen drug surveillance systems in order to combat counterfeit and substandard medicines. Highlighting one program in particular, USP’s new Global Health Monographs address essential medicines that have a major health impact (e.g., malaria) or are used to treat neglected diseases in underserved communities outside of the US. Pharmaceutical companies can get involved by donating specifications and materials for the development of Global Health Monographs.

PharmTech: Are there harmonization programs companies can participate in?

USP: USP encourages companies to participate in its harmonization efforts by reviewing and commenting on proposed harmonized standards that are published in USP’s free online Pharmacopeial Forum. Product innovators can work with USP in advance of losing their exclusivity to establish a standard that can be harmonized with other pharmacopeias. Interested parties can also view information about standards currently being harmonized as well as those that have completed the process on USP’s website.