Current Good Manufacturing Practice (CGMP)

What is Current Good Manufacturing Practice?

Current Good Manufacturing Practice (CGMP) is a set of regulations enforced by the U.S. Food and Drug Administration (FDA). They were established to provide systems that ensure proper monitoring, design, and control of manufacturing processes and facilities.

Medication manufacturers can adhere to CGMP by:

  • Establishing strong quality management systems
  • Establishing robust operating procedures
  • Obtaining raw materials of an appropriate quality
  • Maintaining reliable testing laboratories
  • Detecting and investigating product quality deviations

How does CGMP improve healthcare?

Current Good Manufacturing Practice aims to prevent mix-ups, contamination, failure, deviations, and errors. Adhering to CGMP regulations ensures that manufactured drugs meet their quality standards and produces higher-quality medications that maintain their strength, identity, purity, and quality.

CGMP is important because a consumer cannot detect that a drug product is safe or will work solely through touch, sight, or smell. Because of this, it is crucial for drugs to be manufactured under CGMP regulation conditions and practices to ensure drugs have quality imbued into them during each step of the design and manufacturing process.