Analytical Instrument Qualification and System Validation

Free 67 Page Primer from Agilent Technologies

Written by Dr. Ludwig Huber

Preface from the Author Dr. Ludwig Huber

Qualification of analytical instruments and validation of systems is required by many national and international regulations, quality standards such as ISO 17025 and company policies. If executed correctly, it also helps to improve instrument uptime and to avoid out-of-specification situations (OOS) in laboratories. This “Analytical Instrument Qualification” primer guides analysts, laboratory managers, quality assurance managers and validation professionals through instrument and system validation at minimal extra cost

The concept, examples, templates and recommended procedures are based on my more than 20 years of multinational experience and incorporate knowledge from validation and qualification practices applied at Agilent Technologies and Labcompliance. Readers of this book will learn how to speed up their validation and qualification process, thereby avoiding troublesome reworking and gaining confidence for audits and inspections.

Implementing analytical instrument qualification and computer system validation requires a qualification plan and procedures. Labcompliance provides procedures and qualification examples for analytical instrument qualification and system validation as reference material for audio seminars, for examples see Analytical Instrument Qualification and Validation and Validation and Part 11 Compliance of Chromatographic Data Systems.

Dr. Ludwig Huber
Chief advisor for global FDA compliance
Labcompliance
ludwig_huber@labcompliance.com 

Target Audience

• Lab managers and personnel
• QA managers and personnel
• Analytical scientists
• IT/IS managers and personnel
• Metrology departments
• Regulatory affairs
• Training departments
• Validation specialists
• Consultants
• Teachers

Format/Price/Ordering

• Format: Primer, printed booklet, available as PDF download
• Size: 67pages
• Price: Free of charge
• Available through Agilent Technologies
• Ordering: - from Agilent Website

Chapter Overview

The objective of any chemical analytical measurement is to get consistent, reliable and accurate data. Proper functioning and performance of analytical instruments and computer systems plays a major role in achieving this goal. Therefore, analytical instrument qualification (AIQ) and computer system validation (CSV) should be part of any good analytical practice. There is a second aspect to why validation and qualification are important, and this is equally important for those working in a regulated and in an accredited environment.

Even though frequently not directly spelled out in regulations and official guidelines, such as Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP), or in quality standards, such as the International Organization for Standardization (ISO) Standard 17025, validation and qualification is usually required. This is confirmed by typical statements such as this one that appears in the U.S. cGMP (current Good Manufacturing Practice) regulations: “Equipment shall be routinely calibrated, inspected and checked according to a written program to ensure proper performance” or by the more general requirement “Equipment should be suitable for its intended use”.

Although there were lots of discussions about the approach for qualification of analytical instruments in the 90’s and in the early years of this century, this has changed since the USP has published the final version of the chapter <1058> entitled Analytical Instrument Qualification.

Following a literature and regulatory overview, this primer will provide information on the entire qualification and validation process from planning, writing specifications as well as vendor qualification to installation, initial and on-going operation.

It covers:

• Literature overview with milestones on instrument qualification and system validation in laboratories
•  Overview on regulations and quality standards with impact on analytical instrument qualification
•  Qualification of equipment hardware, for example, a spectrometer or liquid chromatograph
•  Validation of analytical computerized systems
•  Implementing USP chapter <1058>.

Special focus is placed on getting a good understanding of and implementing USP chapter <1058>. After an introduction to the chapter’s approach for instrument qualification, this primer will lead you through individual qualification phases and give recommendations for implementation.

Because of the nature and size of this primer, all the details of operational qualification and system validation cannot be given. For more details, please refer to accreditation and complete compliance packages for ISO17025, Laboratory Compliance and Computer Validation. .

Table of Contents

1. Introduction

• Literature Overview
• Terminology: Validation vs. Qualification
• Components of Analytical Data Quality

2. Regulations and Quality Standards

• Good Laboratory Practice Regulations
• Current Good Manufacturing Practice Regulations
• International Conference for Harmonization
• Pharmaceutical Inspection Convention Scheme (PIC/S)
• ISO/IEC 17025
• 21 CFR Part 11 – FDA’s Regulation on Electronic Records and Signatures
• Learning from Regulations and Quality Standards

3. Qualification of Analytical Instruments

• Qualification Planning
• Design Qualification
• Specifications
• Vendor Assessment
• Installation Qualification
• Testing for Installation Qualification
• Operational Qualification
• Performance Qualification
• (Preventive) Maintenance and Repair
• Change Control

4. Validation of Software and Computer Systems

• Master and Project Planning
• Requirement Specifications
• Vendor Assessment
• Installation Qualification
• Operational Qualification
• Performance Qualification
• Configuration Management and Change Control
• Validation Reports
• Validation of Existing/legacy Systems
• Validation of Spreadsheet Applications

5. Implementing USP Chapter <1058>

• <1058> Instrument Groups
• Allocating Instrument into Instrument Groups
• Procedures and Qualification Protocols for Three Groups
• Communication and Training
  - Users
  - Quality Assurance
  - Developers and Manufacturers

6. References

7. Glossary

The author

The author, Dr. Ludwig Huber, is an international expert on validation and compliance in regulated industries and laboratories. He has been responsible for the compliance program at Hewlett Packard and Agilent Technologies for more than fifteen years. He serves as a consultant for the industry and regulatory agencies on local and international compliance issues. He has been a member of the US PDA task force on 21 CFR Part11 and of the GAMP Special Interest Group for Laboratory Computer Systems. He is also on the advisory board for the European Compliance Academy and is a member of IVT task force on network qualification. Several of his previous books have been bestsellers and several times he has been ranked as number one presenter at various international conferences. For publications, presentations and other achievements, click here