For analytical laboratory equipment, is PQ = calibration criteria?

GOOD VALIDATION PRACTICE (cGVP) LABORATORY, METHOD AND ANALYTICAL VALIDATION
1

for analytical equipments most of them are ‘off the shelf’, pre configured equipments,
viz., analytical balances, pH meters, hardness testers, FTIR, UV-spectrophotometers, HPLCs etc.,

for above groups of equipments, can we consider PQ = calibration / performance verification criteria?

2

No, PQ entails:

  • Establishing documented evidence providing a high degree of assurance that the instrument will operate to pre-established specifications corresponding to its routine day to day operations
  • Documenting then the systems required to maintain the instrument in its qualified state have been established

In my experience “calibration” is usually carried out during OQ

3

[quote=David1]No, PQ entails:

  • Establishing documented evidence providing a high degree of assurance that the instrument will operate to pre-established specifications corresponding to its routine day to day operations
  • Documenting then the systems required to maintain the instrument in its qualified state have been established

In my experience “calibration” is usually carried out during OQ[/quote]

for analytical equipments can you pl. help me understand the PQ & OQ parameters please.

4

Please see http://www.learnaboutgmp.com/book/an-easy-to-understand-guide-to-hplc-validation-8
http://www.learnaboutgmp.com/book/an-easy-to-understand-guide-to-hplc-validation-8

This describes how to qualify an HPLC, covering all topics. It is excellent value for money at $29.99

Hope this helps

Dr David Trew
BSc (Hons), PhD, CChem MRSC

David Trew Consulting Ltd

Providing scientific and quality management services to chemistry based businesses and the laboratory service industry

5

Hello,

A good starting point is USP 1058.

This will allow you to determine what is required.

Good luck