Showing posts with label Qualification. Show all posts
Showing posts with label Qualification. Show all posts

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Design Qualification- DQ | Instrument and Equipment

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.

As per the european commission  definition, DQ is  the documented verification that the proposed design of the systems, facilities and equipment is suitable for the intended purpose.

DQ is also a shared responsibility between the user and the vendor of any equipment or an instrument:

Design Qualification

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:

DQ should ensure that the  instruments which is to be used have all the necessary functions and performance criteria that will enable them to be successfully implemented for the intended application and to meet business requirement.

Errors in DQ can have a tremendous technical and business impact, and therefore a sufficient amount of time and resources should be invested in the DQ phase. For example, setting wrong operational specifications for an HPLC system can substantially increase the workload for OQ testing, and selecting a vendor with insufficient support capability can decrease instrument up-time with a negative business impact.

The user defines his/her requirement specifications and compares them with the vendor's specifications.

"Deviations from approved standards of calibration on critical instruments should be investigated to determine if these could have had an impact on the quality of the intermediate(s) or API(s)  manufactured using this equipment since the last successful calibration.

From the above post you might have got some of the information about it, after DQ, IQ, OQ and PQ are done..So this post is about Design Qualification and get more information about other types please visit other related articles.

Installation Qualification (IQ) | Equipment and Instrument

Operational Qualification (OQ) | Instrument and Equipment

Operational Qualification

Design Qualification Installation Qualification Performance Qualification
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.

Here during Operational Qualification more emphasis should be placed on " in the selected environment". Testing of instrument hardware at the user's site is required because instrument characteristics can change when shipped from the vendor to the user, for example through mechanical vibration.

Major activities which are conducted during Operational Qualification are as follows:

  • 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.)
Some of the tests carried out during operational specification are (example HPLC) :
  1. Pump flow Accuracy and Precision.:  This test uses a calibrated digital flow meter to determine the accuracy and precision of solvent flow rate.
  2. Column Temperature Accuracy and Stability : This test uses a calibrated digital thermometer to determine the accuracy and stability of column temperature.
  3. Wavelength Accuracy:  This test uses a traceable standard or water to determine wavelength accuracy.
  4. Signal Noise and Drift: This test determines signal noise and drift.
  5. Injection Precision:  This test uses a traceable standard to determine injection carry over.
  6. Signal to Noise: This test uses a traceable standard or water to determine signal to noise.
  7. Response Linearity: This test uses a traceable standard to determine response linearity.
  8. Gradient composition: This test uses a tracer to determine solvent gradient composition accuracy, stability and linearity.
  9. Sample Temperature Accuracy: This test uses a traceable digital thermometer to determine sample temperature accuracy.
To get more details to know more about quality assurance also check DQ, IQ, OQ and PQ to know about calibration and validation.

Performance Qualification (PQ) | Instrument and Equipment

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