Good Manufacturing Practice (GMP) regulations help the U.S. Food and Drug Administration (FDA) confirm the safety, quality, and efficacy of drugs, including drugs contained in a medicated feed. The FDA carefully monitors facilities that manufacture, process, package or hold medicated feed to ensure aminal 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, label and pack their medicated feeds.
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 225
• Ensure the safety, purity and efficacy of medicated feeds
• Comply with federal and statutory laws and regulations
• Ensure the safety of products for the administration to animals
• Meet requirements for GMP compliance or certification
• Improved structure, processes and procedures internally
How We Can Help
The ISO 9001 Group understands CFR Part 225 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.
Our proven, hands-on GMP consulting service ensures that your manufacturing practices comply with FDA regulations and pass FDA inspections.
21 CFR Part 225 Overview
Subpart A – General provisions
Subpart B – Construction and Maintenance of Facilities and Equipment
• Use of work areas, equipment, and storage areas for other manufacturing and storage purpose
Subpart C – Product Quality Control
• Laboratory controls
• Equipment cleanout procedures
Subpart D – Packaging and Labeling
Subpart E – Records and Reports
• Master record file and production records
• Distribution records
• Complaint files
Subpart F Facilities and Equipment
• Buildings and grounds
• Work and storage areas
Subpart G – Product Quality Assurance
• Laboratory assays
Equipment cleanout procedures
Subpart H – Labeling
Subpart I – Records
Formula, production, and distribution records
Visit the U.S. Food and Drug Administration‘s website to learn more about Good Manufacturing Practice (GMP) regulations.