GMP Compliance Manufacturing

Do you produce and distribute regulated products, medical devices, pharmaceuticals, cosmetics? Core Compliance works with all regulated industries to provide consulting for GMP compliance manufacturing. Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any regulated production that cannot be eliminated through testing the final product. Core Compliance has FDA industry expertise in-depth knowledge of cGMP regulations from clinical development through post-approval drug and biotech product manufacture.

See FDA facts about current good manufacturing practices– FDA GMP Facts

Road Map to cGMP Compliance

Core Compliance provides a clear road map to cGMP compliance for regulated manufacturing facilities including supplement, skin care, medical devices, pharmaceuticals companies to become FDA GMP compliant. We evaluate your current systems and ensure proper design, monitoring, and control of manufacturing processes and facilities to meet FDA requirements. We create customized training courses designed specifically for your manufacturing organization, personnel, lead & internal auditors, and field service staff. Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated products (food, drugs, biologic, and devices) are known as current good manufacturing practices (CGMP’s). 

 cGMP Compliance Road Map 

 Establishing documentation requirements and processes for the facility, equipment, products, ingredients raw materials, production, laboratory controls, records, labeling, and complaints. We share this road map with executive management to align internal goals and objectives and share FDA GMP requirements to develop milestones and a timeline to GMP compliance.

GMP Consulting Services

 Core Compliance provides GMP consulting services to ensure compliance to FDA requirements. We do a comprehensive review of the manufacturing facility, Equipment, Products, Ingredients Raw Materials, Production Process, Laboratory Controls, Process of Records, Labeling management for an initial health check. 

• Identify Gaps develop road map to GMP compliance
• Develop customized /compliant processes and procedures controls
• Develop Quality Management System (QMS) ISO 13485 ISO 9001
• Develop FDA 21 CFR part 820 Quality System Regulation (QSR)
• Develop & Design processes for Facility, Equipment, Labeling, Packaging
• Implementation, Deployment, Training- New processes, systems, best practices
• Internal Audit Training/Management Review
• cGMP certificate