Good Manufacturing Practice (GMP) regulations help the U.S. Food and Drug Administration (FDA) protect animals by confirming the safety, quality, and efficacy of Type A medicated articles. The FDA carefully monitors manufacturers, processors, packagers and holders of Type A drugs to ensure they are safe for use in the manufacturing of another medicated article or feed. 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, pack or hold their Type A medicated article.
Contact us today to learn more about our GMP consulting services and how we can assist your organization with GMP compliance.
Benefits of 21 CFR Part 226
• Ensure the quality and efficacy of Type A medicated article(s)
• Comply with federal and statutory laws and regulations
• Ensure the safety of Type A medicated article(s) for use in other medicated articles or feeds
• Ensure products are safe for animal consumption
• Meet requirements for GMP compliance or certification
How We Can Help
The ISO 9001 Group understands CFR Part 226 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.
Federal Regulations:
• 21 CFR Part 226. Current Good Manufacturing Practice for Type A Medicated Articles
Our proven, hands-on GMP consulting service ensures that your food manufacturing practices comply with FDA regulations and pass FDA inspections.
21 CFR Part 226 Overview
Subpart A – General provisions
Subpart B – Construction and Maintenance of Facilities and Equipment
• Buildings
• Equipment
Subpart C – Product Quality Control
• Production and control procedures
• Components
• Laboratory controls
Subpart D – Packaging and Labeling
• Packaging and labeling.
Subpart E – Records and Reports
• Master-formula and batch-production records
• Distribution records
• Complaint files
Visit the U.S. Food and Drug Administration‘s website to learn more about Good Manufacturing Practice (GMP) regulations.