cGMP and the Role of Pharmacy in Early Phase Clinical Trials

This white paper discusses the critical role of Clinical Pharmacology Units (CPUs) in early phase clinical trials, particularly focusing on adherence to Current Good Manufacturing Practice (cGMP) regulations. It outlines how clinical study research pharmacists are involved in various processes such as investigational drug product (IDP) compounding, dose management, and ensuring the safety of both patients and trial personnel. The paper details the complexities of compounding investigational drugs, including the preparation of placebos and the importance of maintaining blinding during trials. It emphasizes the necessity for CPUs to comply with FDA guidelines, which includes having well-controlled environments and systematic evaluations to mitigate potential hazards. Additionally, the document highlights the significance of accurate dose delivery and monitoring during trials, showcasing the multifaceted responsibilities of pharmacists in ensuring compliance with cGMP standards throughout the clinical trial process.