Ensuring Quality & Compliance in Pharmaceutical Raw Materials: gChem’s Approach to ICH Q7 and Supply Chain Integrity

Sponsored by gChem

In this interview, Sandra Reid of gChem explains how the USP grade DMSO product, PROCIPIENT®, stands apart as the only dimethyl sulfoxide manufactured under cGMP conditions in full compliance with ICH Q7 API guidelines. The discussion explores why adherence to ICH Q7 is vital not just for active pharmaceutical ingredients but also for excipients and solvents, and how these practices ultimately safeguard the quality of finished drug products. Viewers will also learn about gChem’s distinctive processes, documentation standards, and supply chain controls that ensure consistency, compliance, and trust across global pharmaceutical markets.

Learning Objectives:

• Explain the importance of ICH Q7 guidelines for API raw materials and their direct impact on final drug product quality.
• Identify key cGMP processes that differentiate gChem’s PROCIPIENT® from other DMSO products not produced under ICH Q7 compliance.
• Understand how gChem applies ICH Q7 principles to excipient and solvent applications, even when not explicitly required.
• Describe the documentation, traceability, and controls gChem maintains when PROCIPIENT® is distributed through third-party agents or distributors.