Subpart E requirements for receiving, testing, approving and retesting components, and for drug product containers and closures.
This module covers Subpart E in full: general requirements for component receipt under 211.80, testing and approval or rejection of components under 211.84, retesting requirements for approved components, containers and closures under 211.87, and the requirements specific to drug product containers and closures under 211.94.
Component control is where a quality problem often first enters a facility, before it ever reaches production. A gap here, an untested lot released to the floor, an expired retest interval, propagates into every batch that uses that component.
Completion certificate, PDF slide download, and access to the complete GMP course library from day one.
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