Thursday, 28 March 2013
Saturday, 16 March 2013
Tuesday, 12 March 2013
Monday, 11 March 2013
Saturday, 9 March 2013
Design Qualification: Let us find out what is the definition of (DQ)? It is the widely asked question while studying qualification of any instrument or equipment. It is the documented collection of activities which define the functional as well as operational specifications of any instrument and the criteria for selection of the vendor based on the intended purpose of the instrument.
The responsibility of any vendor during DQ are:
- To develop and manufacture instruments in a quality control environment.
- To Develop functional and operational product specification.
- To Provide information on how software and instruments are validated during development and supported during the entire life of the products.
- To Allow user audits, if required, and share approaches for development and testing.
The responsibility of any user during DQ are:
- To Describe the problem analysis and selection of the technique.
- To Describe the use which is intended.
- To Describe the environment which is intended (including computer environment).
- To identify or select and document the performance and functional specifications (technical, environmental, safety).
- Select and assess the vendor.
Specifications of DQ:
Operational Qualification is the part of instrument as well as equipment qualification and validation. So what is operational Qualification? It is the documented collection of activities which are necessary to demonstrate that an instrument or equipment will function according to its operational specification in the selected environment.
- Tests that have been developed from knowledge or processes, systems and equipment.
- It also contain tests to include a condition or a set of conditions encompassing upper and lower operation limits.
- Also includes tests such as checking temperature Timer, and wavelength accuracy tests, and linearity testing.
- It also include tests which verify the structural integrity of the equipment such as leak test (HPLC, GC Isolators etc.)
- Pump flow Accuracy and Precision.: This test uses a calibrated digital flow meter to determine the accuracy and precision of solvent flow rate.
- Column Temperature Accuracy and Stability : This test uses a calibrated digital thermometer to determine the accuracy and stability of column temperature.
- Wavelength Accuracy: This test uses a traceable standard or water to determine wavelength accuracy.
- Signal Noise and Drift: This test determines signal noise and drift.
- Injection Precision: This test uses a traceable standard to determine injection carry over.
- Signal to Noise: This test uses a traceable standard or water to determine signal to noise.
- Response Linearity: This test uses a traceable standard to determine response linearity.
- Gradient composition: This test uses a tracer to determine solvent gradient composition accuracy, stability and linearity.
- Sample Temperature Accuracy: This test uses a traceable digital thermometer to determine sample temperature accuracy.
Friday, 8 March 2013
Thursday, 7 March 2013
Monday, 4 March 2013
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