Good Manufacturing Practice (GMP) regulations help the U.S. Food and Drug Administration (FDA) protect consumers by confirming the safety, quality, and efficacy of drugs. The FDA carefully monitors manufacturers, processors, packagers and holders of drug products to ensure consumer safety. The mandated and required GMP regulations cover all aspects of production, including having the necessary facilities, equipment, methods, controls and the ability to manufacture, process, and pack their products.
Contact us today to learn more about our GMP consulting services and how we can assist your organization with GMP compliance.
Benefits of Good Manufacturing Practices (GMPs)
• Ensure consumer safety
• Comply with federal and statutory laws and regulations
• Ensure the safety and efficacy of products
• Reduce consumer risks
• Meet requirements for GMP compliance or certification
• Improved structure, processes and procedures internally
How We Can Help
The ISO 9001 Group understands CFR Part 210 regulations and how to comply with them. Our GMP consulting service provides assistance with FDA registration, pre-audit, FDA inspections and responding to FDA warnings letters. Our GMP consultants will work with you to implement the applicable FDA regulations to ensure effective, efficient and compliant good manufacturing practices.
• 21 CFR Part 210. Current Good Manufacturing Practice in Manufacturing Processing, Packing, or Holding of Drugs
Our proven, hands-on GMP consulting service ensures that your manufacturing practices comply with FDA regulations and pass FDA inspections.
21 CFR Part 210 Overview
Status of current good manufacturing practice regulations
Applicability of current good manufacturing practice regulations
Visit the U.S. Food and Drug Administration‘s website to learn more about Good Manufacturing Practice (GMP) regulations.