Validation of Analytical Test Procedures and Measurement Uncertainty

Validation of Analytical Test Procedures and Measurement Uncertainty

Barcelona, Spain

Course No 15729


Costs

This conference already took place.

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Dr Christopher Burgess, Burgess Analytical Consultancy, UK

Trevor Coomber, Pharmaceutical Development Consultant, UK

Dr Xaver Schratt, LPU Labor für Pharma- und Umweltanalytik GmbH, Germany

Objectives

The objectives of this Education Course are

  • to offer practical solutions for determining the validation characteristics
  • to learn how to deal with measurement uncertainty and to understand its impact on analytical methods validation
  • to discuss the scope of validation necessary to obtain approval by the Registration Authorities (EMA, FDA, MHRA, etc.)
  • to become familiar with the statistical parameters to be applied
  • to understand the qualification of laboratory equipment as a precondition of reliable analytical testing
  • to outline the documentation (SOPs, Validation Protocols and Reports, etc.) which you should have in your lab.
In order to improve the understanding and practical application of the contents of the lectures, workshops will be part of the training course.

Background

Guideline Q2(R1) lists all characteristics to be considered during validation and describes the method of determining the various validation characteristics. Reliable analytical results do not only require validated test procedures but also the use of analytical equipment qualified for its intended purpose. In order to obtain the FDA investigator‘s approval, the qualification of all critical laboratory equipment should be performed in standard IQ/OQ/PQ format. Furthermore, measurement uncertainty is of key importance in analytical instruments qualification as well as in analytical methods validation and transfer. Therefore it is absolutely essential that measurement uncertainty is well understood by everybody who is responsible for generating and evaluating analytical results in GMP controlled laboratories.

Target Group

This interactive Education Course will be of particular interest to Laboratory Managers, Supervisors and Analysts in pharmaceutical quality control departments who have responsibility for the validation of analytical test procedures. Furthermore, this Course is designed for personnel from Quality Assurance, Regulatory Affairs and Contract Laboratories.

Free brochure “Validation of Analytical Test Procedures”

Each participant gets a brochure containing over 200 pages of examples and validation protocols on analytical methods validation for free.

Programme

Validation in Context

  • Components of data quality
  • Integrated Approach to Qualification and Validation
  • Conclusion
Basics of Measurement Uncertainty
  • Why is measurement uncertainty important?
  • Relationship between uncertainty and confidence
  • Uncertainty of measurement
  • What is a measurand
  • Error sources in analysis and testing
Analytical Instrument Qualification
  • Guidance
  • Validation Master Plan
  • Definition of DQ, IQ, OQ and PQ
  • Examples of protocols and documents
  • Change Control
  • Risk assessment
Measurement Uncertainty in Calibration and Qualification of Analytical Instruments
  • Qualification, Calibration & Validation
  • Measurement uncertainty
  • Propagation of Errors
  • Measurement uncertainty of a CRM
  • Detection and quantitation limits
  • Noise & drift
  • Statistical aspects
New Developments in Instrument Qualification - The USP Proposals

Statistical Aspects of Analytical Methods Validation
  • The use (and misuse?) of statistics to support validation data
  • Basic theory of the common statistical techniques
  • Merits, pitfalls and underlying assumptions of particular tests
  • The meaning behind
  • Standard deviation - F-test - t-test
  • ANOVA - Correlation Coefficient
  • Linear regression
  • Exploration of more sophisticated statistical techniques such as interval hypothesis testing and experimental design
Practical Determination of: Robustness Leading to System Suitability Tests
  • Method development cycle
  • Analytical process capability
  • Selecting factors and levels
  • HPLC experimental design example
  • Impact on system suitability tests
Method Validation During the Development Lifeycle
  • Product Development Life Cycle
  • Sources of Guidance
  • Screening and Early Safety Studies
  • Phase 1 Volunteer Studies
  • Phase 2 Clinical trials
  • Towards MAA/NDA
Validation for MAA/NDA Planning and Execution
  • Analytical validation according to USP
  • FDA Guidances for method validation
Validation for MAA/NDA Documentation
  • Validation report
  • Transfer protocol/report
  • Validation documentation for registration
  • Validation software
  • Other Sources of Guidance
Error budgets and reportable values
  • What is a reportable value?
  • OOS, OOE & OOT
  • Method performance and process capability
  • ICH precision approach
  • Measurement Uncertainty approach combined sources of variation
Transfer of Analytical Test Procedures
  • Statistical Tests
  • Analytical significance vs statistical significance
  • Acceptance criteria setting
  • Interval hypotheses

Workshops


During the course, 4 workshops will be conducted in order to deepen the content of the lectures and to discuss practical aspects in detail. Workshops will be offered on the following topics:

Analytical Instrument Qualification
The participants will debate the impact of USP
proposals in a practical context

Validation Plan
The participants will work on testing schedules for the relevant validation parameters.

Method Transfer
The participants will discuss practical details of an
Analytical Methods Transfer.

Validation documents critique
The participants will work, in detail, on a typical case study proposing a suitable program of work for a validation dossier.

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