Module 5 of the GMPify Part 211 Certification Series covers Subparts H and I; the warehousing, distribution, and laboratory control requirements that govern finished product handling and quality verification. This module addresses finished product quarantine and storage condition requirements under §211.142, lot traceability and recall-ready distribution records under §211.150, general laboratory controls including written specifications, reference standards, and instrument calibration under §211.160, full release testing and out-of-specification investigation requirements under §211.165, the written stability programme and annual batch requirements under §211.166, special testing requirements for sterile, pyrogen-free, and ophthalmic products under §211.167, reserve sample retention requirements under §211.170, and penicillin cross-contamination testing under §211.176.

OOS investigation requirements and their relationship to FDA's 2006 OOS guidance are specifically addressed one of the most complex and frequently mishandled areas in pharmaceutical QC.

Suitable for: QC laboratory personnel, QA, warehouse and logistics, regulatory affairs, and anyone involved in batch release decisions.

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

Source: 21 CFR Part 211 Subparts H & I, eCFR