Regulatory Compliance

• Regulatory authorities, such as the FDA (Food and Drug Administration) and EMA (European Medicines Agency), mandate stability testing as part of the drug approval process. Comprehensive stability data is required to demonstrate that a product meets quality standards throughout its shelf life.
• The pharmaceutical industry is highly regulated, with strict guidelines set by regulatory bodies such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Calibration plays a critical role in meeting these compliance requirements. Regulatory agencies expect pharmaceutical companies to maintain comprehensive calibration records, demonstrating that all instruments and equipment used in manufacturing, quality control, and research are regularly calibrated. Compliance with these standards not only ensures product quality but also reduces the risk of regulatory penalties, recalls, and potential harm to patients.