The U.S. Food and Drug Administration carefully monitors drug manufacturers’ compliance with its Good Manufacturing Practice (GMP) regulations. The mandated and required GMP regulations help the FDA protect consumers by confirming the safety, quality, and effectiveness of drugs. Good Manufacturing Practice (GMP) ensures products are produced consistently in a controlled manner according to quality standards, such as ISO 9001. Companies that produce cannabis and cannabidiol (CBD) products should comply with GMP regulations, including having the necessary facilities, equipment, methods, controls and the ability to manufacture, process, and pack their products.
Contact us today to find out more about how The ISO 9001 Group can assist your organization achieve its business goals.
Benefits of Good Manufacturing Practice (GMP)
• Ensure consumer safety
• Comply with federal and statutory laws and regulations
• Meet requirement for GMP or management system certification, such as ISO 9001 or ISO 17025
• Ensure the safety and efficacy of products
• Reduce consumer risks
• Improved structure, processes and procedures internally
How We Can Help
The ISO 9001 Group understands the FDA’s GMP requirements and how to comply with them. Our consultants will work to implement the applicable regulatory requirements and management system(s) to ensure an effective, efficient and compliant cannabis and CBD good manufacturing practices. This may include:
• 21 CFR Part 211. Current Good Manufacturing Practice for Finished Pharmaceuticals
• ISO 9001 Quality Management System
• ISO 17025 Laboratory Management System
Our proven 4 step process ensures that your cannabis and CBD good manufacturing practices meet the specific needs of your organization and ensures compliance with FDA, quality and cannabinoid profile requirements.
Good Manufacturing Practice (GMP) Overview
• Subpart A – General provisions
• Subpart B – Organization and Personnel
• Subpart C – Buildings and Facilities
• Subpart D – Equipment
• Subpart E – Control of Components and Drug Product Containers and Closures
• Subpart F – Production and Process Controls
• Subpart G – Packaging and Labeling Control
• Subpart H – Holding and Distribution
• Subpart I – Laboratory Controls
• Subpart J – Records and Reports
• Subpart K – Returned and salvaged drug products