Good Manufacturing Practice (GMP) regulations help the U.S. Food and Drug Administration (FDA) protect consumers by confirming the safety, quality, and efficacy of dietary supplements. The FDA carefully monitors manufacturers, packagers, labelers, importers, holders and distributors of dietary supplements to ensure consumer safety. The mandated and required GMP regulations are applicable to all aspects of production and operations, including having the necessary personnel, plant, equipment, process control systems, laboratory operations and quality controls to ensure the quality, packaging and labeling of dietary supplements.
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 111
• Ensure consumer safety
• Comply with federal and statutory laws and regulations
• Ensure the safety, quality and efficacy of dietary supplements
• Reduce risk and recalls
• Meet requirements for GMP compliance or certification
• Improved structure, processes and procedures internally
How We Can Help
The ISO 9001 Group understands 21 CFR Part 111 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 dietary supplement manufacturing and distribution practices comply with FDA regulations and pass FDA inspections.
21 CFR Part 111 Overview
Subpart A – General provisions
Subpart B – Personnel
Subpart C – Physical Plant and Grounds
Subpart D – Equipment and Utensils
Subpart E – Requirement to Establish a Production and Process Control System
Subpart F – Production and Process Control System: Requirements for Quality Control
Subpart G – Production and Process Control System: Requirements for Components, Packaging, and Labels and for Product That You Receive for Packaging or Labeling as a Dietary Supplement
Subpart H – Production and Process Control System: Requirements for the Master Manufacturing Record
Subpart I – Production and Process Control System: Requirements for the Batch Production Record
Subpart J – Production and Process Control System: Requirements for Laboratory Operations
Subpart K – Production and Process Control System: Requirements for Manufacturing Operations
Subpart L – Production and Process Control System: Requirements for Packaging and Labeling Operations
Subpart M – Holding and Distributing
Subpart N – Returned Dietary Supplements
Subpart O – Product Complaints
Subpart P – Records and Recordkeeping
Visit the U.S. Food and Drug Administration‘s website to learn more about Good Manufacturing Practice (GMP) regulations.