USP <671> - Containers - Performance Testing

What it says

Containers intended for pharmaceutical use must meet defined performance tests appropriate to their classification, including light transmission testing for light-resistant containers and moisture permeation testing for tight containers, confirming the container actually delivers the protection its classification implies.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• This chapter supplies the actual pass or fail performance tests behind the container classification terminology defined in USP <659>, so a container is only properly called light-resistant or tight once it has demonstrated that performance under this chapter's test methods.
• A packaging component sourced from a new supplier or manufactured with a different material formulation can perform differently under these tests even if it looks identical to the previous packaging.
• Moisture permeation performance connects directly to a product's shelf-life stability data, since a container that permits more moisture ingress than assumed during stability testing can invalidate the basis for the labeled expiration date.

What inspectors look for

• Whether container performance testing, such as light transmission or moisture permeation, was actually performed on the specific packaging configuration used for the marketed product.
• Whether a change in packaging supplier or material was evaluated against this chapter's performance tests before being implemented.
• Whether container performance data is consistent with the assumptions used in the product's stability program and labeled shelf life.

Related regulations