Quality Management Systems, Good Manufacturing Practices, Quality Systems Regulations, ISO 13485

Quality System Regulation
Good Manufacturing Practices

Introduction

Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMP’s).

Manufacturers must ensure quality in their products whilst meeting customer requirements and specifications. This is only achievable in a consistent way when a Quality Management System QMS is implemented and followed. Lacking quality in the products and business operations translates into customer complaints, increased rate of returns, business losses and have legal implications risking the overall business operation. However, implementing a QMS improves organizational effectiveness, customer satisfaction, increases compliance to regulations, organizational culture and improves documentation and workflow.

Current Good Manufacturing Practices CGMP regulations enforced by the FDA provide for systems to assure proper design, monitoring, and control of manufacturing processes and facilities. It is the responsibility of each manufacturer to establish requirements for each type or family of devices that will result in devices that are safe and effective, and to establish methods and procedures to design, produce and distribute devices that meet the quality system requirements.