Saturday, 9 March 2013

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.