Mexican Good Manufacturing Practices for Medicines
Mexico's official standard for GMP of medicines for human use (NORMA Oficial Mexicana NOM-059-SSA1-2015, "Buenas prácticas de fabricación de medicamentos"), published in the Diario Oficial de la Federación on 5 February 2016. It is the fundamental GMP requirement enforced by COFEPRIS across manufacturing, quality control, storage, and distribution.
Establishments that manufacture medicines for human use for the Mexican market. NOM-059 sets the minimum GMP requirements; product- and process-specific NOMs apply alongside it.
- 01Meet the minimum GMP requirements of NOM-059-SSA1-2015 for human-use medicines
- 02Maintain qualification, validation, and quality-control documentation
- 03Operate a recall programme for product that does not meet quality standards
Published in the DOF on 5 February 2016, superseding NOM-059-SSA1-2013.
NOM-059-SSA1-2015: frequently asked questions
Quick answers to common questions about NOM-059-SSA1-2015.
What is NOM-059-SSA1-2015?
NOM-059-SSA1-2015 — Mexican Good Manufacturing Practices for Medicines — is a regulation issued by the Comisión Federal para la Protección contra Riesgos Sanitarios (Mexico). Mexico's official standard for GMP of medicines for human use (NORMA Oficial Mexicana NOM-059-SSA1-2015, "Buenas prácticas de fabricación de medicamentos"), published in the Diario Oficial de la Federación on 5 February 2016. It is the fundamental GMP requirement enforced by COFEPRIS across manufacturing, quality control, storage, and distribution.
Who does NOM-059-SSA1-2015 apply to?
Establishments that manufacture medicines for human use for the Mexican market. NOM-059 sets the minimum GMP requirements; product- and process-specific NOMs apply alongside it.
What are the key requirements of NOM-059-SSA1-2015?
COFEPRIS NOM-059-SSA1-2015 requires, among other things: Meet the minimum GMP requirements of NOM-059-SSA1-2015 for human-use medicines; Maintain qualification, validation, and quality-control documentation; Operate a recall programme for product that does not meet quality standards.
When was NOM-059-SSA1-2015 last updated?
The current version of NOM-059-SSA1-2015 dates from February 2016. Published in the DOF on 5 February 2016, superseding NOM-059-SSA1-2013.
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 NOM-059-SSA1-2015 — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.