Remspec Corporation
Validation, IQ, OQ, PQ, Good Laboratory Practice

In recent years there has been a substantial increase in automated analytical systems being introduced into the analytical laboratory and directly into processes. This has gone 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 plays an important role.

To to work in a GLP environment today, all analytical systems need 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.

The four components of Equipment Qualification "EQ"

DQ Design Qualification
Performance and feature requirements for the hardware and software
Design Qualification 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. Remspec provides full support to the purchasing Managers to allow them to make their choice of instrument.

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

OQ Operational Qualification
Remspec Engineer performs during instrument installation
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 Remspec.
PQ Performance Qualification
PQ To be met by the instrument
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 Remspec can provide software tools and test recommendations to aid with PQ.

GLP Qualification Procedures

Design Qualification
In order to meet the needs of our customers, Remspec has always committed itself to a continuously high standard of quality and innovation in production, service, and support. Remspec's ongoing commitment to providing the best infrared fiber-optic analytical systems is evidenced by our portfolio of patents and our 17 year track record in providing immersion probe systems that have the best signal-to-noise performance in the industry and can be dismantled moved and reassembled without recalibration.

Installation and Operational Qualification
Depending upon the hardware components with which the spectrometer is equipped and depending on the type of probes, a series of precisely defined tests must be executed as part of the OQ process. The test results and raw data are calculated and recorded in paper format or tamper evident electronic data format to which a signature may be applied by pen or the digital signature feature of the electronic database in which they are stored. For ReactionView® systems equipped with an ATR probe the two critical tests are a noise test and a chemical sensitivity test where a known pure compound or stable mixture is measured at a fixed temperature to determine the absorbance of reference peaks in the standard sample. Wavelength calibration is maintained by an internal self calibration feature in the VizIR&trade software that can be activated by the user at any time.

Performance Qualification
Good Laboratory Practice or GLP software or procedures are the final component with which Remspec helps to guarantee consistent spectrometer operation under the highest quality requirements. Well-chosen tests evaluate software and hardware components in a semi automatic manner, covering the setup of the experiments as well as the data acquisition and generation of the final test results. The tests are similar to the OQ tests that an engineer will run during the installation of the instrument. GLP Software Digitally locked macros are used to measure test spectra under defined conditions and the required data is then derived from the spectra by locked methods embedded in the macros. The macros can be easily adjusted then locked to meet the individual demands of the environment in which the system is installed. Additional tests can be added either "on site" (by the customer/user) or by Remspec. Conclusion With the GLP software macros, Remspec offers the right solution for every aspect of "Analytical Method Validation".