Colombian Good Manufacturing Practices for Medicines
Colombia’s GMP manuals and inspection guides for medicine manufacturers, issued 6 April 2016 and published in Diario Oficial No. 49.840 on 10 April 2016. Two bodies, two roles, and they are easy to conflate: the resolution is an act of the **Ministerio de Salud y Protección Social**, made under Decreto-ley 4107 de 2011 and developing Decreto 677 de 1995, while **INVIMA** is the authority that inspects and issues the Certificado de Cumplimiento de las Buenas Prácticas de Manufactura against it. The manuals are built on the WHO Expert Committee reports — Annex 4 of Report 37 and Annex 6 of Report 45 — which INVIMA and the Ministry reviewed before adoption.
What this does not cover
stated in the document's own scope- Covers GMP for medicine manufacturers; other product classes follow their own Colombian instruments.
- Adopts the WHO GMP manuals for manufacturing, not the marketing-authorisation (registro sanitario) decision, which INVIMA handles separately.
- Sets the GMP requirement and inspection guides, not the analytical methods, which derive from the applicable pharmacopoeia.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
Resolución 1160 de 2016 sets Colombia’s Good Manufacturing Practices manuals and inspection guides for medicine manufacturers. Issued by the Ministerio de Salud y Protección Social, it adopts GMP manuals based on the World Health Organization’s GMP guidance — specifically Annex 4 of the WHO Expert Committee’s 37th report and Annex 6 of its 45th report (published as WHO TRS 908 and 961) — and gives them regulatory effect in Colombia. INVIMA, the national food and drug surveillance institute, is the authority that inspects against these manuals and issues the GMP compliance certificate a manufacturer needs. The resolution covers the quality system, personnel, premises, documentation, production, quality control and validation in the WHO GMP form.
Scope & applicability
Article 2 binds manufacturers of medicines “ubicados en el territorio nacional o fuera de él” — inside Colombia or outside it — whose products are marketed in Colombia, across their manufacturing and quality-control processes. The same article names INVIMA as the body responsible for issuing the GMP compliance certificate, so the resolution defines both the standard and who certifies against it.
Legal basis & how it acquires force
The resolution is an act of Colombia’s Ministerio de Salud y Protección Social, made under the health-supply framework of Decreto 677 de 1995 and related legislation, and it carries the force of regulation for the Colombian market. Its mechanism is adoption by reference: rather than restating GMP from scratch, it adopts the WHO Technical Report Series annexes as the applicable manuals and directs INVIMA to certify compliance. So the binding obligation is the Colombian resolution, with the WHO annexes supplying its technical content.
Document structure
| Part | Covers |
|---|---|
| Adopted WHO GMP manual | The GMP manual based on Annex 4 of the WHO Expert Committee’s 37th report and Annex 6 of its 45th report, adopted as the applicable requirement |
| Quality management and personnel | The quality system, organisation, training, and personnel hygiene |
| Premises, equipment, and documentation | Facilities and equipment, and the documentation and records system |
| Production and quality control | Manufacturing operations, in-process control, and the quality-control laboratory |
| Inspection guides | The guides INVIMA applies when assessing compliance and issuing certification |
Quick reference · The four annexes of Resolución 1160
The resolution is a wrapper: its substance is in four annexes, which are integral parts of the act. Annexes 1 and 2 are the standards; 3 and 4 are the instruments used to verify them.
| Annex | What it contains |
|---|---|
| Anexo 1 | Manual de Buenas Prácticas de Manufactura para Medicamentos: Principios Fundamentales |
| Anexo 2 | Manual de Buenas Prácticas de Manufactura para medicamentos estériles |
| Anexo 3 | Inspection guide for non-sterile manufacture and process validation — replaced by Resolución 2190 de 2020 |
| Anexo 4 | The remaining verification instrument for laboratories and production establishments |
Certification requires compliance with both manuals where sterile products are involved — the sterile manual supplements the fundamental-principles manual rather than replacing it.
Source: Resolución 1160 de 2016 arts. 1, 3–5, Diario Oficial No. 49.840, 10 April 2016. Verify against the current text before relying on it for a submission.
Key requirements
- Comply with the Manual de BPM: Principios Fundamentales (Anexo 1) for all medicine manufacture
- Comply additionally with the sterile-medicines manual (Anexo 2) where sterile products are made — certification requires both
- Expect inspection against the guides in Anexos 3 and 4, which are integral parts of the resolution rather than guidance
- Hold a current INVIMA Certificado de Cumplimiento de las Buenas Prácticas de Manufactura
- Apply the requirements whether the site is in Colombia or abroad, if the product is marketed in Colombia
Implementation tips
- Cite the Ministerio de Salud y Protección Social as the issuer and INVIMA as the certifier — conflating them is the most common error in Colombian regulatory correspondence
- Map the quality system to WHO TRS Report 37 Annex 4 and Report 45 Annex 6, which the manuals are structured on, rather than to EU GMP chapter numbering
- Check Anexo 3 against Resolución 2190 de 2020, which replaced the article adopting it — the inspection guide in force is not the one first published in 2016
- Do not plan around PIC/S mutual recognition: Colombia is not a participating authority, so a PIC/S certificate does not substitute for INVIMA certification
Revision notes
Issued 6 April 2016 by the Ministerio de Salud y Protección Social and published in Diario Oficial No. 49.840 on 10 April 2016, after a public consultation that ran 4–22 January 2016. Article 5, which adopts the inspection guide for non-sterile manufacture and process validation, was subsequently replaced by article 1 of Resolución 2190 de 2020 — so the guide in force is the one that resolution adopts, based on Annex 4 of WHO Technical Report 37 (TRS 908).
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
Colombia anchors its GMP to the WHO Technical Report Series annexes adopted by Resolución 1160 de 2016 — the WHO GMP reference, not the PIC/S Guide. In Latin America, only ANMAT (Argentina), COFEPRIS (Mexico) and ANVISA (Brazil) have joined PIC/S; INVIMA has not. INVIMA does, however, sit on the WHO transitional list of WHO-Listed Authorities, a WHO recognition of its regulatory maturity that is distinct from PIC/S membership.
Resolución 1160 de 2016: frequently asked questions
Quick answers to common questions about Resolución 1160 de 2016.
What is Colombia’s GMP based on?
Resolución 1160 de 2016 adopts GMP manuals based on Annex 4 of the WHO Expert Committee’s 37th report and Annex 6 of its 45th report (published as WHO TRS 908 and 961), and gives them regulatory effect for the Colombian market.
Is Colombia a PIC/S member?
No. In Latin America only Argentina (ANMAT), Mexico (COFEPRIS) and Brazil (ANVISA) have joined PIC/S. Colombia anchors its GMP to the WHO reference instead, and INVIMA appears on WHO’s transitional list of WHO-Listed Authorities.
Who issues Colombia’s GMP certificate?
INVIMA — the Instituto Nacional de Vigilancia de Medicamentos y Alimentos — inspects manufacturers against the adopted WHO GMP manuals and issues the GMP compliance certificate.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.