Peruvian GMP Manual for Pharmaceutical Products
Peru's Manual of Good Manufacturing Practices for pharmaceutical products, approved by Decreto Supremo N° 021-2018-SA, which also amends the regulation for registration, control, and sanitary surveillance of pharmaceutical products and medical devices. GMP is enforced by DIGEMID and is grounded in WHO GMP guidance.
Manufacturers of pharmaceutical products for the Peruvian market. The manual sets the GMP requirements DIGEMID inspects against; registration and surveillance requirements sit alongside it.
- 01Comply with the WHO-based GMP manual approved by DS 021-2018-SA
- 02Maintain qualification, validation, and quality-control documentation
- 03Meet DIGEMID registration and sanitary-surveillance requirements
Approved by Decreto Supremo N° 021-2018-SA (2018), updating Peru's pharmaceutical GMP framework.
DS 021-2018-SA: frequently asked questions
Quick answers to common questions about DS 021-2018-SA.
What is DS 021-2018-SA?
DS 021-2018-SA — Peruvian GMP Manual for Pharmaceutical Products — is a regulation issued by the Dirección General de Medicamentos, Insumos y Drogas (Peru). Peru's Manual of Good Manufacturing Practices for pharmaceutical products, approved by Decreto Supremo N° 021-2018-SA, which also amends the regulation for registration, control, and sanitary surveillance of pharmaceutical products and medical devices. GMP is enforced by DIGEMID and is grounded in WHO GMP guidance.
Who does DS 021-2018-SA apply to?
Manufacturers of pharmaceutical products for the Peruvian market. The manual sets the GMP requirements DIGEMID inspects against; registration and surveillance requirements sit alongside it.
What are the key requirements of DS 021-2018-SA?
DIGEMID DS 021-2018-SA requires, among other things: Comply with the WHO-based GMP manual approved by DS 021-2018-SA; Maintain qualification, validation, and quality-control documentation; Meet DIGEMID registration and sanitary-surveillance requirements.
When was DS 021-2018-SA last updated?
The current version of DS 021-2018-SA dates from August 2018. Approved by Decreto Supremo N° 021-2018-SA (2018), updating Peru's pharmaceutical GMP framework.
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