DQD systems are fully validated and include the following:

Design Qualification (DQ)

• Generation of user requirement specifications
• Verification of these type corresponding user requirement specifications
• Supplier evaluation / audit
• Check the challenge of the design by GMP audits
• Product Quality Impact Assessment
• Specifying validation documentation requirements of suppliers
• A greements with the suppliers about the performance targets
• Factory Acceptance Test (FAT ), Site Acceptance Test (SAT ) and commissioning procedures

Installation Qualification (IQ)

DQD ensures systems have been delivered and installed in accordance with design drawings, vendor recommendations and in-house requirements. A record of the main features of the equipment or system installed are produced, and ensures that they are supported by sufficient and appropriate documentation to implement satisfactory operation, maintenance and control of changes.

Operational Qualification (OQ)

All DQD systems are taken into service before the start of OQ, to ensure they are complete, and that the system assembly and pre-qualification checks ensure that the device is fully functional and that documentation is complete.

Performance Qualification (PQ)

DQD provides documented evidence, based on a series of production runs, that the system or equipment performs consistently and produces components or products meeting pre-determined specifications.