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.
What this does not cover
stated in the document's own scope- Covers GMP for pharmaceutical products; medical devices, though named in the amended registration regulation, follow their own applicable requirements.
- Sets manufacturing GMP, not the marketing-registration decision itself, which is part of the broader sanitary-registration regime.
- Establishes the GMP manual, not the internal 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
Decreto Supremo N° 021-2018-SA approves Peru’s Manual of Good Manufacturing Practices for pharmaceutical products, and at the same time amends the regulation governing registration, control and sanitary surveillance of pharmaceutical products and medical devices. The Manual sets the GMP a manufacturer must meet — quality management, personnel, premises and equipment, documentation, production, quality control, validation, complaints and recalls — and is grounded in WHO GMP guidance. DIGEMID, Peru’s directorate for medicines, supplies and drugs, is the authority that applies these requirements and issues the corresponding GMP certification.
Scope & applicability
Manufacturers of pharmaceutical products for the Peruvian market. The manual sets the GMP requirements DIGEMID inspects against; registration and surveillance requirements sit alongside it.
Legal basis & how it acquires force
A Decreto Supremo is a binding supreme decree of the Peruvian executive, so DS 021-2018-SA carries the force of regulation for the Peruvian market rather than being guidance. It sits within the framework of Peru’s medicines law (Ley N° 29459 on pharmaceutical products, medical devices and sanitary products) and its implementing regulation. Because the same decree also amends the registration and sanitary-surveillance regulation, GMP compliance is tied into the wider authorisation and surveillance regime DIGEMID administers.
Document structure
| Part | Covers |
|---|---|
| Quality management | The quality system and quality-unit responsibilities |
| Personnel and premises | Organisation, training, hygiene, and facility and equipment requirements |
| Documentation | The documentation system, master and batch records, and data controls |
| Production and quality control | Manufacturing operations, in-process control, and the quality-control laboratory |
| Validation and qualification | Qualification of facilities and equipment and process, cleaning, and analytical validation |
| Complaints, recalls, and self-inspection | Complaint handling, recall, self-inspection, and contracted activities |
Key requirements
- 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
Implementation tips
- Verify the current DS 021-2018-SA manual text and later amendments
Revision notes
Approved by Decreto Supremo N° 021-2018-SA (2018), updating Peru's pharmaceutical GMP framework.
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
The Manual is grounded in WHO Good Manufacturing Practices guidance, the reference that many national authorities in the region adopt directly, so Peru’s requirements track the WHO GMP text. This keeps Peruvian GMP broadly comparable with the international baseline, while the binding obligation remains the Peruvian decree as applied and certified by DIGEMID.
DS 021-2018-SA: frequently asked questions
Quick answers to common questions about DS 021-2018-SA.
What does DS 021-2018-SA approve?
It approves Peru’s Manual of Good Manufacturing Practices for pharmaceutical products, and in the same decree amends the regulation for registration, control and sanitary surveillance of pharmaceutical products and medical devices.
Which authority enforces GMP in Peru?
DIGEMID — the Dirección General de Medicamentos, Insumos y Drogas — applies the GMP requirements and issues the corresponding GMP certification.
What is Peru’s GMP based on?
The Manual is grounded in WHO Good Manufacturing Practices guidance, so its requirements track the WHO GMP reference text.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.