1. IQ Installation Confirmation
Installation Confirmation (IQ) mainly through the installation of the equipment. Confirmation of equipment installation in accordance with the design requirements, documents and accessories are complete, through the inspection and documentation in the form of proof of the existence of the equipment. In other words, by checking the documents and other items, to confirm that the equipment and systems are installed in accordance with the design, and in line with the equipment and system design requirements and standards, and has been properly installed.
IQ installation confirmation includes
? Packaging confirmation
? Equipment list
? Installation process confirmation
? Confirmation of materials (in direct contact with the product)
? Confirmation of the instrument part
? Confirmation of lubricant (lubricant in contact with the product must be food grade)
? Confirmation of various technical drawings and operating instructions
? Confirmation of utility systems
2. DQ Design Confirmation
Design Confirmation (DQ) is clearly explained in the Pharmaceutical Manufacturing Validation Guidelines as "Pre-confirmation, i.e., Design Confirmation, usually refers to the review of the suitability of the technical specifications of the equipment to be ordered and the selection of the vendor to supply it." Meanwhile, in the Guide for the Implementation of Good Manufacturing Practice, it is stated that "Pre-confirmation is the confirmation of the design and selection of the equipment
DQ design confirmation includes
Confirmation of the equipment's performance, material, structure, parts, measuring instruments and suppliers, etc.
Confirmation of the PID diagram
Confirmation of the GAD diagram
Confirmation of the parts list
Confirmation of the GAD diagram< /p>
Parts list
Circuit diagram
3. OQ operation confirmation
Operation confirmation (OQ) is to check and test the operation, operation and control performance of the equipment through the no-load running test through the record and documented to confirm that the pharmaceutical machinery (equipment) in line with the requirements of the production process. After the installation confirmation of the equipment manufacturer and user **** with the validation of the program according to the operation of the confirmation of the performance of the equipment to run in line with the coordination of the confirmation.
OQ operation confirmation includes
Test instrument calibration
Functional testing of equipment/system components
Indicators, interlocks and safety control testing
Alarm testing
Failure to power down and repair
4. PQ performance confirmation
Performance Qualification (PQ) Performance Qualification (PQ) Performance Qualification (PQ) is the confirmation of actual operating results of the equipment, the performance of the equipment, the performance of the equipment, the performance of the equipment, the performance of the equipment, the performance of the equipment. Is a set of pharmaceutical technology under the guidance of industrial load production, with the simulation of production methods, through observation, recording, sampling and testing and other means to collect and analyze data to prove the reliability of pharmaceutical machinery (equipment) operation and adaptability to production.
PQ is a simulation of the production process, by the user in accordance with the pharmaceutical production process requirements for the actual production run, PQ needs to be made according to each set of facilities and equipment and their related processes and procedures for the development of individual confirmation program.
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