The validation of UV spectrophotometer 3Q is to confirm that the related facilities and equipment of the UV spectrophotometer can comply with the standards and requirements of the "Good Manufacturing Practice for Drugs" and JJG178-2007 "Verification Regulations for UV, Visible, and Near Infrared Spectrophotometers", and to confirm that the UV spectrophotometer can be used normally within the predetermined limits and allowable range according to the design, and that the performance of each part can be effectively repeated, maintain stability and reliability continuously, and meet the requirements of the enterprise's use; And develop effective preventive measures for potential risks.
Verification of UV spectrophotometer 3Q
Now let's introduce itVerification of UV spectrophotometer 3QThat isUV spectrophotometerInstallation, operation, performance confirmation plan and report.
purpose
In order to confirm that the facilities and equipment related to the UV spectrophotometer can comply with the standards and requirements of the "Good Manufacturing Practice for Drugs" and JJG178-2007 "Verification Regulations for UV, Visible, and Near Infrared Spectrophotometers", and to confirm that the UV spectrophotometer can be used normally within the predetermined limits and allowable range according to the design, and that the performance of each part can be effectively repeated, maintain stability and reliability continuously, and meet the requirements of the enterprise's use; And develop effective preventive measures for potential risks.
1. By verifying the UV spectrophotometer, potential deviations such as non compliant operation or use of facilities, equipment, and unreasonable system parameter settings are identified and adjusted and corrected to ensure that the operation of relevant facilities, equipment, and systems meets the specified requirements and standards.
2. By verifying the facilities and equipment related to ultraviolet spectrophotometers, effective preventive measures can be developed to mitigate potential risks that may affect the normal use of the enterprise.
3. Confirm that the facilities and equipment related to the ultraviolet spectrophotometer can comply with the standards and requirements of the "Good Manufacturing Practice for Drugs" and JJG178-2007 "Verification Regulations for Ultraviolet, Visible, and Near Infrared Spectrophotometers". Confirm that the ultraviolet spectrophotometer can be used normally within the predetermined limits and allowable range according to the design, and that the performance of each part can be effectively repeated, maintaining stability and reliability continuously, and meeting the requirements of the enterprise's use; And develop effective preventive measures for potential risks.
Performance Qualification
The purpose of performance confirmation is to test the compatibility of the absorption cell, transmittance error and repeatability test, wavelength error and repeatability test, stray light, baseline flatness, noise and drift of the UV visible spectrophotometer under the condition that the operation confirmation meets the requirements, to confirm that it meets the design and usage requirements.