What is a Current Good Manufacturing Practice (CGMP)?

Current good manufacturing practices (cGMPs) are regulations set forth by the FDA to ensure proper design, monitoring, and control of manufacturing processes and facilities. They require pharmaceutical companies to establish a comprehensive quality management system, source quality raw materials, implement robust standard operating procedures (SOPs), investigate product deviations, and maintain reliable testing facilities.

*Source: https://www.fda.gov

Good manufacturing practices (GMPs) focus on five critical factors that are sometimes referred to as the 5 P’s of GMP—people, premises, processes, products, and procedures—to assure consistent product quality and safety.

*Source: https://www.cfpie.com

The 10 principles of GMP are:

1. Develop detailed standard operating procedures (SOPs)
2. Follow procedures
3. Document work
4. Validate all processes and systems
5. Integrate productivity, safety, and quality into facilities and equipment
6. Maintain facilities and equipment
7. Define, develop, and demonstrate job competency
8. Protect products from contamination thorough proper sanitation and hygiene
9. Establish quality controls
10. Conduct routine audits

Follow all protocols and keep meticulous records of your work. Contamination, mix-ups, and errors must all be avoided by the company. Separate the quarantine and completed product testing areas. Prepare methods for handling and storing products, as well as distribution records that will aid in the tracking of shipments.

*Source: https://www.pharmout.net