What is a Current Good Manufacturing Practice (CGMP)?
Current Good Manufacturing Practice Definition
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 (CGMPs). CGMP requirements for devices in part 820 (21 CFR Part 820) were first authorized by section 520(f) of the Federal Food, Drug, and Cosmetic Act.
Source: https://www.fda.gov
FAQs
What is current good manufacturing practices in the pharmaceutical industry?
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
What are the 5 main components of good manufacturing practice?
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
What are the 10 principles of GMP?
The 10 principles of GMP are:
- Develop detailed standard operating procedures (SOPs)
- Follow procedures
- Document work
- Validate all processes and systems
- Integrate productivity, safety, and quality into facilities and equipment
- Maintain facilities and equipment
- Define, develop, and demonstrate job competency
- Protect products from contamination thorough proper sanitation and hygiene
- Establish quality controls
- Conduct routine audits
What is the golden rule of GMP?
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
Best Practices for Quality & Compliance
Read our guides to learn best practices on how to eliminate issues and risks and launch high-quality, compliant products to market.