Deterministic versus probabilistic container closure integrity testing methods, and why CCI is treated as a critical quality attribute.
This course covers why container closure integrity is treated as a critical quality attribute for sterile products, the difference between deterministic and probabilistic CCIT methods and when each applies, the USP <1207> framework for package integrity evaluation, and the regulatory expectation that integrity be demonstrated across a product's full shelf life, not only at release.
A container closure breach is one of the few sterile product failure modes that can go completely undetected by routine testing if integrity is only checked at release. Shelf-life integrity data is what closes that gap, and it is increasingly what inspectors ask to see.
Completion certificate, PDF slide download, and access to the complete GMP course library from day one.
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