Quality Assurance

What is a Quality Management System (QMS)? A QMS is a set of policies, procedures, and processes that are put in place to ensure that a product meets the required quality standards. In pharmaceutical manufacturing, a QMS is put in place to ensure that products are produced consistently and meet regulatory requirements. A QMS includes processes such as quality control, quality assurance, and quality improvement. Why is a QMS Important in Pharmaceutical Manufacturing? The implementation of a robust Quality Management System in pharmaceutical manufacturing is crucial for several reasons: Compliance with Regulatory Standards The pharmaceutical industry is highly regulated, and regulatory bodies such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) require that pharmaceutical manufacturers comply with strict regulations to ensure the safety and efficacy of their products. A Quality Management System is an important tool, among many, that a manufacturer uses to help with compliance with these regulations, reducing the risk of non-compliance and…