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