Validation and Qualification

 

All equipment and analytical instruments in ACDIMA BioCenter are valid and qualified in compliance with:

  • Good Laboratory Practices (GLP) regulations.

  • Good Clinical Practices (GCP) regulations.

  • USP chapter (1058) “Analytical Instrument Qualification”.

  • US FDA 21 CFR 211 guidance for current Good Manufacturing Practice for finished pharmaceuticals (cGMP).

  • European Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Annex 15: Qualification and Validation.

  • Pharmaceutical Inspection Convention Scheme (PIC/S).

 

The type, level, and the number of qualification activities of equipment and analytical instruments depend on their nature. Based on that, there are three main groups: A, B, and C. Group A includes equipment with no measurement capability, group B includes equipment and instruments providing measured values, group C includes analytical instruments integrated with a computerized system. 

The conformance of instruments in each group with the user requirements specifications is determined according to visual observations for group A, specific function test for group B, and specific function and performance tests for group C.

 

The equipment and analytical instruments during their lifecycle are undergoing through a 4Q model; Design Qualification (DQ) Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ) that covers the equipment from its order to its retirements and it consists of:

 

  • Plans: User Requirements Specification (URS), Functional Requirements Specifications (FRS), and Vendor Qualification.

  • Specifications: DQ, IQ, OQ, and PQ protocols.

  • Tests: Execution of the protocols, Standard operating procedures (SOPs), and personnel training records.

  • Maintaining the validated state: configuration management and change control, procedure, operation support, and maintenance.

  • Retirement: Retirement plan and memos.