Good Laboratory Practice

Introduction

In recent years we have seen a vast increase in automated systems being introduced into the analytical laboratory. This development went hand-in-hand with an increasing demand for better quality assurance in all kinds of manufacturing processes. In those areas, where analytical instruments are used to prove the quality of products, Analytical Method Validation (1-3) plays an important role.

Today, all analytical methods, not only NMR, have to follow the general guidelines of Equipment Qualification (EQ). This term summarizes several different aspects of validation in the field of analytical instruments. Frequently one recognizes four main steps involved in Equipment Qualification (table 1).

Design Qualification
DQ

Installation Qualification
IQ

Performance Qualification
PQ

ISO9000, CE

Operational Qualification
OQ

GLP, GCP

To be met by the manufacturer
of the analytical instrument

Bruker Engineer performs
IQ/OQ

To be met by the instrument

Table 1: The four components of Equipment Qualification "EQ"

Design Qualification DQ is intended to be a tool for Laboratory Managers to select the most suitable instrumentation and software for their purpose. DQ defines the functional and operational specifications of the instrument and details the conscious decisions in the selection of the supplier. Bruker places all documents needed for DQ at the disposal of Laboratory Managers.

Installation Qualification IQ falls under the responsibility of Laboratory Managers. IQ is concerned with all the procedures necessary to prepare the site and check the system for installation. Bruker can provide professional site assessment and layout suggestions. For assurance of product quality, Factory Final Test is carried out at Bruker, previous to shipping.

Operational Qualification OQ is used to demonstrate and provide documented evidence that, after installation, the instrument performs according to its intended use. OQ falls under the complete responsibility of Bruker.

Performance Qualification PQ ensures that the instrument continues to function correctly and to a specification appropriate for its routine use. PQ falls under the responsibility of Laboratory Managers, but Bruker provides software tools to aid with PQ.