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Manufacturing
RQA Pharma
Quality System
A quality system is critical for firms operating in regulated environments where compliance with good practices—Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Manufacturing Practices (GMP)—is required. The pharmaceutical quality system is a framework for ensuring that quality is designed and built into each step of the drug manufacturing and production process. It delineates a set of responsibilities, processes, and procedures that pharmaceutical companies should use to maintain the purity, consistency, and quality of their products.
Implementation of a robust pharmaceutical quality system is one way that drug manufacturers can demonstrate their commitment to quality and assure their pharmaceutical supply partners and patients that their products are manufactured to have the desired quality and performance attributes. It helps pharmaceutical companies ensure that their drugs are safe, deliver the intended performance, and consistently meet the needs of customers.
Defining the pharmaceutical quality system
According to the U.S. Food and Drug Administration (FDA), an effective pharmaceutical quality system should help firms ensure compliance with Current Good Manufacturing Practices (CGMPs), and it is the key system evaluated by the FDA during inspections. It is a quality management system that provides pharmaceutical companies with an integrated framework, or an organizational structure, processes, and procedures, for implementing quality assurance, risk management, and continuous improvement in drug manufacturing. It is a set of guidelines, standards, and regulations that firms use to ensure that their medications are safe, stable, and perform as described on the label and over the course of each product's shelf life.
