Module 3 of the GMPify Part 211 Certification Series covers Subpart E

the incoming material control requirements that protect drug product 

quality from the point of receipt through to use in manufacture. This 

module addresses written procedure requirements for all component 

control activities under §211.80, incoming quarantine requirements 

under §211.82, representative sampling and identity testing obligations 

under §211.84 including the per-container identity testing requirement 

that is among the most misunderstood in Part 211 first-in/first-out 

inventory management under §211.86, retesting requirements after 

extended storage or adverse conditions under §211.87, rejected material 

quarantine and disposition under §211.89, and container closure system 

qualification requirements under §211.94.

Real-world examples from FDA's 483 database illustrate the most common 

compliance failures in incoming material control.

Suitable for: QA, warehouse and materials management, procurement, 

laboratory personnel, and anyone involved in incoming material receipt 

and release decisions.

Approx. 30 minutes | 5 assessment questions | Certificate on completion

Source: 21 CFR Part 211 Subpart E, eCFR