Chilean Good Manufacturing Practices
Chile's technical standard on Good Manufacturing Practices for human-use medicines (Norma Técnica N° 127), originally approved by Decreto Exento N° 28 of 2012 and updated by Decreto Exento N° 159 of 2013, under the pharmaceutical control regulation (DS N° 3 of 2010). It is grounded in WHO GMP (Reports 32/33, updated per Report 37) and enforced by the Instituto de Salud Pública (ANAMED).
Laboratories and manufacturers of human-use medicines for the Chilean market. The ISP inspects facilities, equipment, and records against Norma Técnica N° 127 and certifies GMP compliance.
- 01Comply with the WHO-based GMP requirements of Norma Técnica N° 127
- 02Maintain qualification, validation, and quality-control documentation
- 03Pass ISP on-site GMP inspection
Approved by Decreto Exento N° 28 (2012) and updated by Decreto Exento N° 159 (2013), under DS N° 3/2010.
Norma Técnica N° 127: frequently asked questions
Quick answers to common questions about Norma Técnica N° 127.
What is Norma Técnica N° 127?
Norma Técnica N° 127 — Chilean Good Manufacturing Practices — is a regulation issued by the Instituto de Salud Pública de Chile (ANAMED) (Chile). Chile's technical standard on Good Manufacturing Practices for human-use medicines (Norma Técnica N° 127), originally approved by Decreto Exento N° 28 of 2012 and updated by Decreto Exento N° 159 of 2013, under the pharmaceutical control regulation (DS N° 3 of 2010). It is grounded in WHO GMP (Reports 32/33, updated per Report 37) and enforced by the Instituto de Salud Pública (ANAMED).
Who does Norma Técnica N° 127 apply to?
Laboratories and manufacturers of human-use medicines for the Chilean market. The ISP inspects facilities, equipment, and records against Norma Técnica N° 127 and certifies GMP compliance.
What are the key requirements of Norma Técnica N° 127?
ISP Norma Técnica N° 127 requires, among other things: Comply with the WHO-based GMP requirements of Norma Técnica N° 127; Maintain qualification, validation, and quality-control documentation; Pass ISP on-site GMP inspection.
When was Norma Técnica N° 127 last updated?
The current version of Norma Técnica N° 127 dates from January 2013. Approved by Decreto Exento N° 28 (2012) and updated by Decreto Exento N° 159 (2013), under DS N° 3/2010.
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Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
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When Norma Técnica N° 127 — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.