Validation and Qualification in Analytical Laboratories-10-43.docx

1. Introduction

• The purpose of chemical analytical measurement: to get consistent, reliable, and accurate data.

• Incorrect measurement results can lead to:

  • Product recalls due to incorrectly measured specifications.

  • Negative health impacts from drugs with undetected impurities.

  • Danger from harmful contaminants in environmental or food samples.

• Reporting incorrect results leads to loss of confidence in future laboratory results.

• Importance of validation and qualification:

  • Ensures reliability and accuracy within a known confidence level.

  • Required in regulated or accredited environments despite not being directly specified in regulations like GLP/GMP or ISO 17025.

  • Direct impact on product quality and consumer safety, making analytical test results high-risk records.

• Addressing validation issues:

  • FDA guides on analytical and bioanalytical method validation.

  • ICH guidelines for the validation of analytical procedures.

  • USP draft chapter on analytical instrument qualification.

  • ISPE good practices guide on the validation of laboratory systems.

  • EPA guidance on methods development and validation.

  • AOAC guidelines on method validation.

  • ISO guides on control charts and qualification of reference material.

  • EU Directive on Validation and Qualification.

• Historical context of validation in analytical laboratories:

  • Validation has always been performed by good scientists prior to routine analysis.

• Current challenges in validation and qualification:

  • Lack of documented procedures and results.

  • Partial validation of total analytical procedures.

  • Unqualified accessories and materials for equipment qualification.

  • Unknown operational qualification parameters.

  • Uncertainties in software and computer system validation procedures.

  • One-time validation and qualification, rather than ongoing processes.

  • Incorrect risk-based validation.

  • Confusion over criteria for existing system qualification.

• The intention of this book:

  • Provide answers to these challenges with common sense recommendations and practical experience.

• Description of book structure:

  • Covers practical aspects of validation and qualification, including regulations, quality standards, terminology, risk assessment, and qualifications of people.

  • Appendices include practical examples and procedures.

  • Focus on chromatography but applicable to other analytical techniques.

• Importance of evaluating and documenting recommendations made in the book.

• The necessity of considering compliance and business risk in validation.

• Essential goal: generate valid, reliable analytical data.

• The challenge: optimal validation effort without excessive validation burden.

• Cost of validation increases exponentially from no validation to complete validation.