Annual Retraining & Requalification Frameworks Designing an Effective Annual Retraining and Requalification Framework in Pharma Introduction Annual retraining and requalification are essential elements of a pharmaceutical quality system. They ensure that personnel remain current with regulatory expectations, SOP revisions, and validation practices. Regulatory authorities such as the FDA, EMA, and WHO mandate periodic retraining and requalification for GMP-critical roles. This guide provides a structured framework to implement a comprehensive retraining and requalification system across validation, QA/QC, engineering, and manufacturing teams. Regulatory Expectations Key regulatory references related to retraining include: 21 CFR 211.25(a): “Each person engaged in the manufacture, processing, packing,…