Audits

(G4-EC7, G4-EC8, EG-EC9, G4-LA12, G4-LA14, G4-LA15, G4-EN32, G4-EN33)

In order to confirm that the suppliers responsible for manufacturing our products comply with high quality, environmental, social and ethical standards, they are evaluated through audits that verify the basic aspects mentioned below, as part of the establishment and standardization of high level processes.

Basic aspects evaluated in audits for the selection and monitoring of suppliers

Product quality and responsibility

  • Regulatory framework, applicable certificates and licenses
  • Quality management system
  • Analytical and testing methods
  • Product handling, transportation and storage
  • Safety and hygiene controls
  • Purchase of raw materials and packaging
  • Management of subcontracted input, process and activities vendors
  • Control of input handling, distribution and storage
  • Input analysis certificates
  • Risk management
  • Technology transfer systems
  • Control of manufacturing operations
  • Product revisions
  • Release of finished product
  • Complaint management
  • Non-compliant product handling
  • Product returns and market withdrawal

Labor considerations

  • Organizational structure
  • Academic training and experience
  • Health, safety and hygiene
  • Health responsibility
  • Training and capacity-building
  • Facilities, equipment and maintenance
  • Staff services areas
  • Workplace violence prevention mechanisms

Pharmacovigilance and Technovigilance

  • Training
  • Suspicion reports
  • Adverse reactions or adverse incidents
  • Safety reports

Environmental concerns

  • Legal, ecological and health provisions
  • Waste management, storage and disposal
  • Precautions for preventing product contamination
  • Water systems
  • Safety and hygiene guidelines
  • Greenhouse gas emissions (GHG)

Social Responsibility (SR)

  • Code of ethics and/or conduct
  • Working conditions (remuneration and hours)
  • Respect of human rights (principles of equality, non-discrimination, non forced labor, non-child labor, freedom of association and collective bargaining, rights of the indigenous population, etc.)
  • Equity and inclusion
  • Actual or potential impact on communities
  • Measures against corruption and unfair practices
  • Acknowledgment of third-party regarding SR

Genomma Lab Internacional investigates and requires that its value chain does not work with conditions of forced labor, child labor, or under any other condition that violates the Human Rights of our suppliers’ workers, as a result of our good practices, in 2016 none of these practices occurred in our supply chain. Likewise, the suppliers who work directly manufacturing our products have signed our Code of Conduct and Ethics.

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Reporte de Sustentabilidad 2016 de Genomma Lab Internacional

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