Container closure systems suitability information

A packaging system found acceptable for one drug product is not automatically assumed to be appropriate for another. Each application should contain enough information to show that each proposed container closure system and its components are suitable for its intended use. 

Although ophthalmic drug products can be considered topical products, they have been grouped here with inject-ables because they are required to be sterile (21 CFR 200.50(a)(2)) and the descriptive, suitability, and quality control information is typically the same as that for an injectable drug product. Because ophthalmic drug products are applied to the eye, compatibility and safety should also address the container closure system s potential to form substances which irritate the eye or introduce particulate matter into the product (see USP <771> Ophthalmic Ointments). 

A description of all the container/closure system configurations for the drug to be marketed should be presented. In addition, stability data and any other information that support the suitability of the container/closure components, including specifications and test methods, should be indicated. 

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