1. Understand the GMP Requirements: Familiarize yourself with the specific GMP requirements applicable to your type of product (pharmaceutical, medical device, or natural health product). The requirements and guidelines may vary for each category.
2. Prepare for Compliance: Assess your current operations, facility, equipment, processes, and personnel against the GMP guidelines to identify areas that need improvement.
3. Design Your Facility: If you are establishing a new facility, ensure that it is designed and constructed by GMP principles, including proper layout, sanitation, ventilation, and security measures.
4. Develop Quality Systems: Implement quality systems and procedures that cover all aspects of manufacturing, testing, quality control, documentation, and personnel training.
5. Perform Training: Train your personnel on GMP requirements, quality systems, hygiene practices, and other relevant topics.
6. Implement Quality Control Measures: Develop and implement procedures for testing and releasing raw materials, intermediates, and finished products. Establish specifications for quality control testing and methods.
7. Maintain Documentation: Create and maintain accurate and complete records of all manufacturing, testing, and distribution activities.
8. Conduct Internal Audits: Regularly conduct internal audits to assess your compliance with GMP guidelines and identify areas for improvement.
9. Obtain a Site License: Manufacturers and importers of natural health products in Canada require a Site License to demonstrate GMP compliance. Apply for the license through Health Canada’s Natural and Non-Prescription Health Products Directorate (NNHPD).
10. Implement Corrective Actions: – Address any deficiencies identified during internal audits and make necessary improvements to your processes and systems.
11. Submission and Inspection: – If you are a pharmaceutical manufacturer, packager, or labeler, Health Canada will conduct an inspection to assess your compliance with GMP requirements. Submit the appropriate application and documents to Health Canada’s Health Products and Food Branch (HPFB).
12. Compliance Verification: – Health Canada will review your application, documentation, and inspection results to determine if your facility meets GMP standards.
13. Certification Issuance: – If you meet the GMP requirements, Health Canada will issue a Drug Establishment License (DEL) for pharmaceuticals or a Site License for natural health products.