Personnel Training in Pharmaceutical Manufacturing

Competency and efficiency of pharmaceutical manufacturing personnel is critical to a safe and successful manufacturing process. The Code of Federal Regulations (CFR) provides mandatory rules for personnel training, while Food and Drug Administration (FDA) drafts guidance documents and good training practices (GTPs). This article focuses on how to develop and implement a training strategy that is compliant to CFR and FDA guidance. Keywords: pharmaceutical manufacturing personnel; code of federal regulations (CFR); food and drug administration (FDA); good training practices (GTPs); training strategy