QUALIFICATION/VERIFICATION OF INSTALLATION, OPERATION AND PERFORMANCE

Concerned With Compliance? We Can Help!

IQ and OQ/PV services include comprehensive handbooks to guide the instrument user.

In many business fields, analysts must comply with a number of regulations. Although the ultimate responsibility for complicance remains with the user, the manufacturers of analytical equipment can assist in a variety of ways.

Among the pertinent regulations are Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP), and quality or accreditation standards such as ISO 9000, European Norm EN 45001, and ISO Guide 25. Pharmaceutical analysts must consider the requirements of the United States and European Pharmacopeias (USP and EP).

Hewlett-Packard offers services for installation qualification (IQ) and operational qualification/ performance verification (OQ/PV) for its major products in the capillary electrophoresis (CE), high- performance liquid chromatography (HPLC) and UV-visible spectroscopy product lines.

Users Determine Limits

Installation qualification is included in the standard installation service and can be requested by users. IQ verifies and documents completeness of shipment. Usually, a single measurement is performed to prove system functionality. For CE and HPLC products, a standard sample is injected; for UV-visible spectroscopy products, a spectrum is measured. Standards and procedures are included with the shipment, if required.

Operational qualification/performance verification is designed to verify and document the instrument's ability to meet certain performance criteria. Users determine acceptance limits according to their own specific needs. In general, OQ/PV performs several system tests, reports the results and documents whether the acceptance criteria were met.

Qualifying an HPLC System

To qualify a complete HPLC system, a series of tests must be performed. These tests include noise, drift, linearity and wavelength accuracy of the detector; carryover, linearity and reproducibility of the injector; gradient performance of the pump; and temperature accuracy and precision of the column compartment. The user must define acceptance criteria for each.

Once scheduled, the tests can be performed automatically with the HP ChemStation for HPLC, using a set of calibrated and traceable standards for most. The ChemStation then calculates and prints a report in which the actual results are compared with specified acceptance criteria.

Testing a CE System

The OQ/PV test for the HP ^3DCE system should be performed before its first use in regulated environments, after extended use and, in particular, after repair. Procedures used to test the instrument's functionality have been developed specifically for capillary electrophoresis.

The OQ/PV kit includes a users guide, test sample, buffer and capillary, and a 3.5-inch diskette containing the methods, sequences and spectral library necessary for running the test. The users guide describes how to prepare the system, how to run each test, and how to interpret the results. It includes advice on appropriate action should the system fail the test. The users guide is written in the form of a standard operating procedure (SOP); the individual methods and sequences are also included. The entire test procedure is designed to be performed in half a day.

OQ/PV for UV-Visible Systems

The HP ChemStation software for the HP 8453 UV-visible spectroscopy system includes a semiautomatic procedure for OQ/PV of the spectrophotometer, but obtaining suitable standards remains difficult. Solid standards, such as those available from NIST, are expensive and do not fully meet the regulatory requirements. For example, a good, solid standard for the photometric accuracy in the UV region is not available. Liquid standards meet regulatory needs, but need to be freshly prepared before the test, are time-consuming and prone to error.

To solve these problems, Hewlett-Packard has introduced a set of low-cost, prepared liquid standards that are easy to use. Simply break open the ampoule, pour into the cuvette and measure. The only additional requirement is water as a blank for the noncritical stray-light tests. All other reference solvents are included.

Three stray-light tests are included to meet both European Pharmacopeia and U.S. regulatory needs. The new standards are easy to use and meet the regulatory requirements exactly. They come complete with a certificate of analysis for traceability.

With the liquid standards, flow-through cuvettes are recommended to improve sample handling. The HP-developed procedure uses a syringe to introduce the sample, significantly reducing test time and the risk of cross-contamination. The procedures for performing OQ/PV are fully documented.

IQ and OQ/PV Service

HP offers IQ and OQ/PV services. Specially trained service personnel perform all procedures using calibrated tools and standards. The services save valuable time and allow analysts to concentrate on more important tasks.