The Product Information Reports (PIRs) are documents that have been developed to provide critical technical information and guidance related to the manufacture of medicines that are of global public health importance. Each PIR synthesizes available physicochemical, pharmacokinetic, toxicological, and other information for a given product and analyzes key manufacturing challenges.
PIRs are intended to support informed decision making regarding product development, scale-up, and manufacturing by proactively identifying and addressing potential manufacturing issues. The PIRs may also be used by stakeholders concerned with expanding the supply of and access to essential medicines to develop an understanding of how product development and manufacturing challenges impact the availability of these products.
PQM recognizes there are multiple groups working in this space and invites the submission of Product Information Reports from external organizations that may already have compiled similar reports. For submission inquiries, please email PQM@usp.org.