Sr Regulatory & Policy Comms Mgr USP East Fallowfield
All medicine must meet strict regulatory guidelines for final drug products and ultimately patient safety. In drug development, it is crucial to prioritize high-quality materials and excipients from the outset. To lower costs, drug manufacturers may not pay for full traceability or GMP-standard manufacture materials in a feasibility stage and use a lower-quality of the regulated material. Drug manufacturers should begin considering the final manufacturing process at the earliest opportunity.
As a drug product evolves to commercial availability, the approach to ancillary, raw and starting materials and excipients should change. Most of these materials have a grading system to determine if they are in compliance with the regulatory guidance at each stage. Supply chain transparency, material and excipient qualification along with documentation should begin at the initial stages of drug development to mitigate risks for materials in the final drug product.
Learning Objectives:
Define "grades" of materials and excipients
Recognize when the appropriate "grade" should be used
Utilize material and excipient supplier qualification and documentation