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