Design Confirmation (DQ), Installation Confirmation (IQ), Operational Confirmation (OQ), Performance Confirmation (PQ)
Equipment/Instrumentation Selection (DQ):
Design Confirmation shall demonstrate that the design of the plant, facilities, and equipment is in accordance with the intended use and requirements; documented written evidence that the facilities, equipment systems have been designed in accordance with the requirements of the GMP, and that such written evidence Description of the designed facilities, equipment systems are suitable for the intended use, and the designed facilities, equipment system components and units based on current engineering theory and practice principles and considerations and user requirements.
Installation Qualification (IQ):
Installation Qualification shall demonstrate that the plant, facilities, and equipment have been constructed and installed in accordance with the design criteria; the IQ shall list all identifying information to be documented, including: the name of the equipment, the description of the system, the equipment identification number (hardware and software), the location, the requirement for ancillary facilities, the connections, and the installation characteristics. matches the purchase list and that all drawings, manuals, spare parts, supplier information and other relevant documents are complete.
Operational Qualification (OQ):
Operational Qualification (OQ) should demonstrate that the plant, facilities, and equipment are operating in accordance with design criteria. It should include information that all components of a plant, facility, or system are functioning properly according to specified requirements, including: all normal operation tests, all warning points, all switches and displays, interactive controls, and other operating functions, SOPs for operation, maintenance, and inspection (or information in equipment-specific manuals), information on training of operators, and the need for the OQ to describe all operations and to establish The OQ needs to describe all operations and set operating standards.
Extended information:
1. Performance confirmation should demonstrate that the plant, facilities, and equipment are capable of sustained compliance with the standard under normal operating methods and process conditions.
2, this part of the validation is carried out after the completion and approval of the installation and operation confirmation. pq document describes the procedures for demonstrating that the equipment system can consistently meet the system requirements under both routine operating conditions and extreme conditions.
The PQ document should include a description of the initial procedure, details of the performance tests to be performed, and acceptance criteria for each test.The PQ also requires that the equipment and facilities system involves ancillary equipment and facilities that have also been validated or commissioned and accepted.