OQ/PQ Operating Instructions M1393R0 Page 7 of 60
CHAPTER 1
Introduction
1.1 The Purpose of OQ/PQ
An increasing number of standards and official regulations require that the end user is able
to provide evidence that the instrumentation used for analytical work is working in a
satisfactory manner. In the same manner, quality management according to ISO 9000
(and similar standards) requires that the user monitor and document the ability of the
equipment to obtain valid data on a periodic basis. This manual provides a detailed series
of procedures to perform these Operational Qualification (OQ) and Performance
Qualification (PQ) protocols on the LC Packings UltiMate system components.
The validation procedures described herein are designed to demonstrate that the
instrument was working in an acceptable manner using the standards provided on the day
of validation. It is likely that the instrument performance will vary over time due to small
changes in the various components in the instrument and the validation protocol should be
performed on a periodic basis. The frequency of validation is dependent on the level of
usage of the system and the degree of tolerance that is acceptable for the system.
1.2 Defining the Limits
According to ‘The development and application of guidance on equipment qualification of
analytical instruments’ of P. Bedson and M. Sargent [Accred. Qual. Assur. (1996) 1: 265 -
274] the following definitions apply:
• Operational Qualification (OQ) – The purpose of the Operational Qualification is to
demonstrate and document that an analytical system functions according to its
specifications when specific environmental conditions are taken into account. In this
specification, the supplier must define exactly the conditions that must be observed
for the measurement.
• Performance Qualification (PQ) – The purpose of the Performance Qualification is to
demonstrate and document that an analytical system is capable of accurately
measuring the concentration of one or more compounds in a standard sample.
To simplify the overall qualification protocol, the same procedures can be used for both OQ
and PQ, but the tolerances used for Performance Qualification are less restrictive than
those used for Operational Qualification.
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