2022.09 UB Farmatec 18
2022.07 UB SDM 99

The Quality Assurance Department is a support area for the processes carried out at SDM and UB-Farmatec, ensuring they are developed in accordance with the certification standards (ISO 9001 for SDM or GMP for UB-Farmatec).

Support is provided for all documentation-related tasks: drafting Standard Operating Procedures (SOPs), reviewing and approving work protocols, and archiving and safeguarding quality documentation.

Other areas where Quality Assurance is involved include:
  • Regular self-inspections
  • Management and execution of calibrations
  • Management of manufacturing or control equipment and services
  • Management of quality indicators and continuous improvement
  • Management of incidents and preventive actions
  • Ongoing and initial training of collaborators at both centers

Finally, notable services and projects developed by Quality Assurance include: development and implementation of the quality system for new TAC laboratories, GMP audits for API manufacturers and pharmaceutical warehouses, drafting expert or technical reports, and customized in-company training plans.