In the pharmaceutical sector, the established documentary evidence that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting pre-determined acceptance criteria. It confirms that equipment, processes, and activities involved in manufacturing consistently lead to the expected outcomes. An example includes rigorously testing a sterilization process to demonstrate its effectiveness in eliminating viable microorganisms, ensuring product safety.
This concept is critical for ensuring product quality, patient safety, and regulatory compliance. The practice provides confidence that pharmaceutical products are safe, effective, and reliable. Historically, growing awareness of the need to prevent errors and variability in manufacturing processes has propelled this focus, leading to stringent regulatory requirements globally. It ensures public health by minimizing the risk of adverse drug reactions or ineffective treatments.
