Qualification & Validation

GXP PharmAid produces all documents as may occur in connection with a qualification and validation process. We are writing protocols, performing tests and reporting qualifications and validations for customers.

We prepare and implement the following documents and activities related to the qualifications  and validations:

• User Requirement Specification (URS)
• Factory Acceptance Test (FAT)
• Site Acceptance Test (SAT)

• Design qualification (DQ)
• Installation qualification (IQ)
• Operation qualification (OQ)
• Performance qualification (PQ)

• Process Validation (PV)
• Cleaning Validation (Cleaning Validation (CV)

This is done according to DK, EU and FDA regulatory requirements and guidelines.