Quality Assurance Unit (QA)

Coordinator

Marta Mitjà Ventura
mmitja@santpau.cat

Team

Agostina Robledo López
Jordina Pasqual Grinyó

Functions

Establish mechanisms to assess Quality and Best Scientific Practices at IIB Sant Pau, promoting continuous improvement and excellence goals.

Establishment and monitoring of IIB Sant Pau’s Quality Assurance Program.

Implement and follow-up of the Integrated Management System, including the establishment of improvement policies under the following standards:

• Good Manufacturing Practices, specific to Advanced Therapy Medicinal Products, at the Clean Room.
• Good Clinical Practices, at CIM Sant Pau Phase I Unit
• Good Clinical Practices, at Medical Oncology Phase I Unit.
• ISO 9001, Quality Management System, at Scientific and Technical Services.
• UNE 166002, R+D+i Management System, at Innovation and Transference Unit.
• Good Laboratory Practices.

Quality Management in the different stages of Advanced Therapy Medicinal Product’s production.

Certification link

Perform internal audits:

• Batch documentation of Advanced Therapy Medicinal Products.
• Clinical Trial protocols, data bases, experimental phases, installations, processes and final reports.
• Scientific and Technical Services.
• Suppliers.

Coordinate, oversee and follow up of the external Inspections /audits from:

• Public Administration (ex: Generalitat, Española de Medicamentos y Productos Sanitarios …).
• Clinical Trial Promoters.
• Certification Entities.

Provide support for Quality Management System’s design and implementation in other areas.

Coordinate the ISO Quality Committee and the Good Manufacturing Practices Committee.

Provide support at design stage of the new IR-HSCSP Clean Room.