ABSTRACT
A packaging component is any single part of a container closure system. Typical components are containers, container liners, closures, closure liners, stopper overseals, container inner seals, administration ports, overwraps, administration accessories, and container labels. The United States Pharmacopeial Convention has established requirements for containers, which are described in many of the drug product monographs in the United States Pharmacopeia/National Formulary. “Suitability” refers to the tests and studies used and accepted for the initial qualification of a component, or a container closure system, for its intended use. A container closure system should provide the dosage form with adequate protection from factors that can cause a degradation in the quality of that dosage form over its shelf life. The use of stability studies for monitoring the consistency of a container closure system in terms of compatibility with the dosage form and the degree of protection provided to the dosage form is accepted.
