Ensuring Quality In Clinical-Phase Drug Manufacturing: A Comprehensive Guide

By Ben Frey, Vice President, Compliance & Quality Assurance

Quality Assurance (QA) is essential to clinical-phase drug manufacturing, ensuring investigational drugs meet stringent quality standards necessary for patient safety, product efficacy, and regulatory compliance. In early-phase production, QA focuses on consistency and reliability in small-batch manufacturing, critical for clinical trials. Key QA practices include developing robust Standard Operating Procedures (SOPs), implementing thorough training, and employing risk-based strategies to address potential issues. Challenges in early-phase QA include maintaining consistency in small-scale production, refining manufacturing processes, navigating diverse regulations, and overcoming resource constraints.

A strong QA culture, supported by leadership and cross-functional collaboration, drives continuous improvement and ensures compliance with regulatory standards. This foundational approach not only safeguards patient safety but also supports the successful development of investigational therapies. By prioritizing QA, ProPharma helps clients meet quality and compliance needs, ensuring the reliability and efficacy of each batch produced.