Colombian Good Manufacturing Practices for Medicines
Colombia's GMP manuals and inspection guides for medicine manufacturers (Resolución 1160 de 2016 of the Ministerio de Salud y Protección Social). It adopts manuals based on WHO Technical Report Series (Report 37 Annex 4 and Report 45 Annex 6), and INVIMA issues the GMP compliance certificate. Colombia joined PIC/S in 2021.
Manufacturers — inside or outside Colombia — of medicines marketed in Colombia. The resolution's annexes cover general GMP, sterile-product GMP, and laboratory inspection guides.
- 01Comply with the WHO-based GMP manuals adopted by Resolución 1160 de 2016
- 02Hold a valid INVIMA GMP compliance certificate
- 03Meet sterile-product GMP expectations where applicable
Issued in 2016 by the Ministerio de Salud y Protección Social, adopting updated WHO GMP manuals.
Resolución 1160 de 2016: frequently asked questions
Quick answers to common questions about Resolución 1160 de 2016.
What is Resolución 1160 de 2016?
Resolución 1160 de 2016 — Colombian Good Manufacturing Practices for Medicines — is a regulation issued by the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (Colombia). Colombia's GMP manuals and inspection guides for medicine manufacturers (Resolución 1160 de 2016 of the Ministerio de Salud y Protección Social). It adopts manuals based on WHO Technical Report Series (Report 37 Annex 4 and Report 45 Annex 6), and INVIMA issues the GMP compliance certificate. Colombia joined PIC/S in 2021.
Who does Resolución 1160 de 2016 apply to?
Manufacturers — inside or outside Colombia — of medicines marketed in Colombia. The resolution's annexes cover general GMP, sterile-product GMP, and laboratory inspection guides.
What are the key requirements of Resolución 1160 de 2016?
INVIMA Resolución 1160 de 2016 requires, among other things: Comply with the WHO-based GMP manuals adopted by Resolución 1160 de 2016; Hold a valid INVIMA GMP compliance certificate; Meet sterile-product GMP expectations where applicable.
When was Resolución 1160 de 2016 last updated?
The current version of Resolución 1160 de 2016 dates from April 2016. Issued in 2016 by the Ministerio de Salud y Protección Social, adopting updated WHO GMP manuals.
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
Track the standards that move
When Resolución 1160 de 2016 — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.