3.2.S.2.6 - Container Closure System

The description and specification of packaging materials should be provided.

• For functional secondary packaging materials, information relevant to the function should be provided.
• For non-functional secondary packaging materials, a brief description should be provided.
• The specification of primary packaging materials should contain identification and description tests.

A discussion regarding the following attributes should be provided, as applicable:

1. Protection from light;
2. Protection from moisture;
3. Compatibility between the primary packaging material and the API, including the possibility of sorption to container or leaching of impurities that might compromise the API quality; and
4. Compliance with requirements for food grade materials.