The document outlines the process and requirements for obtaining, renewing, or extending Good Practice certifications for pharmaceutical manufacturers and related establishments before INVIMA.
It covers the following information:
- Step-by-step procedures for requesting certification, extension, or renewal visits for Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other related certifications
- Required documents, forms, and supporting materials for each type of inspection or certification request
- Instructions for payment of fees, including domestic and international payment methods
- Guidelines specific to different product categories such as medicines, biological products, medicinal gases, homeopathic medicines, phytotherapeutic products, dietary supplements, and radiopharmaceuticals
- Submission protocols, including online filing through the INVIMA website and business hours for processing
- Steps for requesting a second inspection to verify outstanding requirements from a previous visit
- Reference to relevant Colombian regulations and resolutions governing Good Practice certifications
- Contact and tracking information for follow-up on submitted request
Source
Select Mandate HA
Select Mandate Function