PURPOSE

This general information chapter presents a framework for the design, justification, and execution of an extractables assessment for pharmaceutical packaging and delivery systems. The chapter establishes critical dimensions of an extractables assessment and discusses practical and technical aspects of each dimension. Although intended to be helpful and generally applicable, the chapter is for informational purposes and does not establish specific extraction conditions, analytical procedures, or mandatory extractables specifications and acceptance criteria for particular packaging and delivery systems or dosage forms; nor does it delineate every situation in which an extractables assessment is required. It is not possible for a general discussion of extractables to anticipate and cover all situations where an extractables assessment might be required. Designing an individual extractables assessment is a process that balances sound science, prudent resource allocation, and effective risk management. Achieving this balance is the responsibility and obligation of the drug product manufacturer and assumes due consideration of all applicable legal and regulatory requirements. The principles and best demonstrated practices outlined in this general chapter represent a consensus interpretation of sound science and can therefore be applied to any situation in which an extractables assessment is required for pharmaceutical application.