Mexico Pharmaceutical GMP Checklist
Comprehensive Mexico pharmaceutical GMP checklist covering NOM-059-SSA1, cleanroom standards, and COFEPRIS manufacturing requirements.
- Industry: Pharmaceutical
- Frequency: Daily
- Estimated Time: 60-90 minutes
- Role: Responsable Sanitario/Director Técnico
- Total Items: 47
- Compliance: NOM-059-SSA1-2015, NOM-073-SSA1-2015, FEUM, COFEPRIS Guidelines
Instalaciones
Facilities
- ¿Áreas limpias clasificadas (ISO)?
- ¿Presiones diferenciales monitoreadas?
- ¿Flujo de aire unidireccional donde aplique?
- ¿Temperatura y HR controladas?
Equipos
Equipment
- ¿Equipos calificados (IQ/OQ/PQ)?
- ¿Mantenimiento preventivo al día?
- ¿Instrumentos calibrados?
Materiales
Materials
- ¿Materias primas en cuarentena antes de liberación?
- ¿Análisis de materias primas realizados?
- ¿Almacenamiento en condiciones controladas?
Producción
Production
- ¿Orden de producción documentada?
- ¿Despeje de línea realizado?
- ¿Controles en proceso realizados?
- ¿Registro de lote completo?
Control de Calidad
Quality control
- ¿Muestreo según procedimiento?
- ¿Análisis de producto terminado completos?
- ¿Liberación de lote documentada?
Documentación
Documentation
- ¿PNO vigentes y disponibles?
- ¿Registros firmados y fechados?
- ¿Desviaciones documentadas y cerradas?
Pre-Assessment Information
Initial assessment documentation and patient/facility identification
- Assessor Name / Credentials
- Assessment Date
- Department / Unit
- Assessment Type (Routine/Annual/Complaint)
- Previous assessment findings reviewed?
Infection Prevention & Control
Verify infection control practices per CDC and Joint Commission standards
- Hand hygiene compliance observed?
- Appropriate PPE available and properly used?
- Isolation precautions properly implemented?
- Sharps containers available and not overfilled?
- High-touch surfaces properly disinfected?
Patient Safety & Identification
Verify patient safety protocols and identification procedures
- Two patient identifiers used before procedures?
- Fall risk assessment completed?
- Call light within patient reach?
- Bed in lowest position with brakes locked?
Medication Safety & Management
Verify medication handling and administration practices
- Medications stored securely and at proper temperature?
- Controlled substances properly secured and counted?
- No expired medications in stock?
- High-alert medications properly labeled?
Environment of Care & Safety
Verify facility environment meets safety standards
- Fire exits clear and unobstructed?
- Emergency equipment functional and accessible?
- Spill kits available and stocked?
- Electrical cords and outlets in safe condition?
Documentation & Regulatory Compliance
Complete assessment documentation and ensure regulatory compliance
- All findings documented with evidence?
- Corrective actions assigned with timeline?
- Staff education provided on identified issues?
- Assessor Signature
- Additional Observations
Related Healthcare Checklists
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Why Use This Mexico Pharmaceutical GMP Checklist?
This mexico pharmaceutical gmp checklist helps pharmaceutical teams maintain compliance and operational excellence. Designed for responsable sanitario/director técnico professionals, this checklist covers 47 critical inspection points across 12 sections. Recommended frequency: daily.
Ensures compliance with NOM-059-SSA1-2015, NOM-073-SSA1-2015, FEUM, COFEPRIS Guidelines. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Mexico Pharmaceutical GMP Checklist cover?
This checklist covers 47 inspection items across 12 sections: Instalaciones, Equipos, Materiales, Producción, Control de Calidad, Documentación, Pre-Assessment Information, Infection Prevention & Control, Patient Safety & Identification, Medication Safety & Management, Environment of Care & Safety, Documentation & Regulatory Compliance. It is designed for pharmaceutical operations and compliance.
How often should this checklist be completed?
This checklist should be completed daily. Each completion takes approximately 60-90 minutes.
Who should use this Mexico Pharmaceutical GMP Checklist?
This checklist is designed for Responsable Sanitario/Director Técnico professionals in the pharmaceutical industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.
Can I download this checklist as a PDF?
Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.