The core objectives of the FDA’s Pharmaceutical Quality (PQ) and Chemistry & Manufacturing Controls (CMC) Project are twofold. First, to develop structured data standards for the PQ/CMC domain, and second, to create a data exchange standard for submitting this structured and standardized drug quality data to the FDA. This effort targets explicitly the information currently encompassed in Module 3 and Module 2.3 of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) defined electronic Common Technical Document (eCTD). More details on the scope and objectives of the project can be found on the FDA’s PQ/CMC webpage.
Samvit Solutions has been one of the key entities partnering with IBM on this PQ/CMC initiated by the FDA. This initiative aims to revolutionize how pharmaceutical companies submit vital drug quality data to the FDA in the future. The structured and computable data standards will enhance the efficiency and accuracy of the drug quality review process.
Samvit Solutions’ team, working with the FDA project leadership, has been leading and facilitating discussions with the drug quality reviewers/Subject Matter Experts from three FDA Centers and collectively developing structured data elements and controlled terminologies standards. This collaborative process has been pivotal in shaping the data standards for the drug quality domain.
A significant aspect of our contribution involves working closely with the FDA’s drug quality reviewers to understand the existing challenges of receiving unstructured CMC data and identifying areas of CTD Module 3 that are amenable to structuring and standardizing. This collaborative process of analysis results in the development of structured and computable data elements and controlled terminology (when applicable) for the larger domain of CMC. Additionally, Samvit analysts develop and maintain the PQ/CMC domain model. In partnership with the NCI EVS team, they register the PQ/CMC-controlled terminology in the National Cancer Institute Thesaurus (NCIt). These steps ensure that the data standards developed are robust, comprehensive, and aligned with existing terminologies and models.
As envisioned by the FDA, the PQ/CMC data exchange standard is being developed as a Health Level 7 (HL7) Fast Health Interoperable Resources (FHIR) representation. This modern approach to data exchange standards aligns with the latest advancements in healthcare. Samvit’s analysts actively participate in the HL7 Biomedical Research & Regulation (BR&R) workgroup and many other relevant HL7 workgroups, contributing to discussions to represent the PQ/CMC structured data elements in FHIR resources. This involvement underscores our commitment to staying abreast of and contributing to leading-edge developments in healthcare IT.
We have been integral in developing the PQ/CMC FHIR Implementation Guide (IG) and constructing reference implementations. This has been pivotal in garnering feedback from pharmaceutical companies via an industry pilot and HL7 FHIR connectathons. This feedback is instrumental in refining the new standard and ensuring that the standards are implementable.
Samvit Solutions’ role in this FDA PQ/CMC project exemplifies our commitment to enhancing healthcare IT standards and our ability to innovate in complex, large-scale projects.