eHandbook: Quality Assurance & Control

The need for pharmaceutical manufacturers to adopt a comprehensive contamination control strategy (CCS) has never been greater to ensure product quality and patient safety, as well as regulatory compliance. The growing complexity of APIs and high-potency products makes robust CCS implementation essential — bringing together facility design, technical systems, and human behavior into a single, risk-based approach.

Advancements in technology — particularly inline analytical testing and robotics — have made it possible for operations teams to prove that the critical steps necessary to dramatically increase automation and reduce variability and human error can be automated. Repetitive manual tasks, like taking and processing samples, can be performed with robotic arms to improve accuracy, efficiency, and safety.

At the same time, validation directly impacts regulatory compliance and product quality and is mandated by regulatory authorities such as the FDA, EMA, and other agencies. While commissioning gets systems ready to run, validation ensures that those systems are compliant and capable of consistently producing quality results.

Sponsored by: LJ Star, Miura America and SpotSee