ABSTRACT
This chapter discusses the important elements of extractables and leachables, with which those in the pharmaceutical industry should be familiar. Drug products, biological products, and delivery devices are regulated worldwide to protect all consumers, although requirements will depend on the various regional legislations. The guiding principles for qualifying products for intended use are rooted in identification and mitigation of risks to drug/biologic product quality and patient safety. In the United States, drugs were first regulated in 1906 to prohibit interstate commerce of misbranded and adulterated foods, drinks, and drugs. This was later revised in 1938 to the Federal FD&C Act to contain new provisions to extend the control to cosmetics and therapeutic devices. The packaging guidance was issued to provide recommendations for the information to be provided in an application for any drug product. The market package for a drug product includes the primary packaging components, secondary package, external packaging, and associated components.
