Risk Management in the Pharmaceutical Product Development Process: White Paper Prepared by PhRMA Drug Product Technology Group

“The manufacture and use of a drug product, including its components, necessarily entail some degree of risk.”—International Conference for Harmonization (ICH) Q9. This paper examines the role of risk management in pharmaceutical product development in the context of patient safety and drug efficacy. Its objective is to contribute to building a common understanding of this quality risk management among the various functional groups involved in developing, testing, manufacturing, and approving of drug products within pharmaceutical companies and regulatory agencies. Selected aspects of drug substance and drug product development are used to demonstrate principles of risk management in action and presented as case studies.