GMP life cycle qualification

With this range of services, COMSER helps you ensure that equipment and facilities used in the pharmaceutical manufacturing meet regulatory requirements, are safe, effective, reliable and compliant with the end user’s requirements. Our focus is to share our experience and put our knowledge at the service of the project. From protocols edition and tests execution, to performing the corresponding verifications in every step of the process as well as providing support during all qualification life cycle of the equipment.

• GMP Equipment Risk Analysis.
• Qualification Strategy Definition.
• Design Qualification (DQ).
• Factory Acceptance Test (FAT).
• Site Acceptance Test (SAT).
• Installation Qualification (IQ).
• Operational Qualification (OQ).
• Performance Qualification (PQ).

All qualification life cycle includes periodic re-qualification as well as qualification of change controls (if applicable) in order to maintain the proper qualified status.

https://comserpharma.com/qualification/