Good Manufacturing Practice (GMP) regulations help the U.S. Food and Drug Administration (FDA) protect consumers by confirming the safety, quality, and efficacy of finished pharmaceutical products. The FDA carefully monitors manufacturers, processors, holders and packagers of pharmaceuticals 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 drug products.
Contact us today to learn more about our 21 CFR 211 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 211 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 211 Overview
Subpart A – General provisions
Subpart B – Organization and Personnel
• Responsibilities of quality control unit
• Personnel qualifications
• Personnel responsibilities
Subpart C – Buildings and Facilities
• Design and construction features
• Ventilation, air filtration, air heating and cooling
• Plumbing, etc.
Subpart D – Equipment
• Equipment design, size, and location
• Equipment construction
• Equipment cleaning and maintenance
• Automatic, mechanical, and electronic equipment, etc.
Subpart E – Control of Components and Drug Product Containers and Closures
• Receipt and storage of untested components, drug product containers, and closures
• Testing and approval or rejection of components, drug product containers, and closures
• Use of approved components, drug product containers, and closures
• Retesting of approved components, drug product containers, and closures, etc.
Subpart F – Production and Process Controls
• Written procedures and deviations
• Charge-in of components
• Calculation of yield
• Equipment identification, etc.
Subpart G – Packaging and Labeling Control
• Materials examination and usage criteria
• Labeling issuance
• Packaging and labeling operations
• Tamper-evident packaging requirements for over-the-counter (OTC) human drug products, etc.
Subpart H – Holding and Distribution
• Warehousing procedures
• Distribution procedures
Subpart I – Laboratory Controls
• Testing and release for distribution
• Stability testing
• Special testing requirements
• Reserve samples, etc.
Subpart J – Records and Reports
• Equipment cleaning and use log
• Component, drug product container, closure, and labeling records
• Master production and control records
• Batch production and control records, etc.
Subpart K – Returned and Salvaged Drug Products
• Returned drug products
• Drug product salvaging
Visit the U.S. Food and Drug Administration‘s website to learn more about Good Manufacturing Practice (GMP) regulations.