Validation of Analytical Test Procedures & Measurement Uncertainty
15-17 October 2024, Copenhagen, Denmark
Course No. 21255
Speakers
Trevor Coomber
Pharmaceutical Development Consultant
Dr. Xaver Schratt
GBA Pharma
Dr. Christopher Burgess
Burgess Analytical Consultancy
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 understand the qualification of laboratory equipment as a precondition of reliable analytical testing
to discuss the scope of qualification & validation necessary
to obtain approval by the Registration Authorities (EMA, FDA, MHRA, etc.)
to become familiar with the statistical parameters to be applied
to outline the documentation (SOPs, Validation Protocols and Reports, etc.) which you should have in your lab.
to provide an outline of the new USP & ICH developments of procedure validation
In order to improve the understanding and practical application of the contents of the lectures, workshops will be part of the training course.
Background
The ICH guideline Q2 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 regulatory approval, the qualification of all critical laboratory equipment must be performed and documented ensuring “fitness for purpose”. 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.
Analytical Procedure Lifecycle Management; the future direction
Course road map
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
USP <1058> Guidance
USP revision process and GAMP
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
Analytical Procedure Lifecycle Management; the Future Direction
Validation; the changing regulatory climate
FDA Process Validation Paradigm shift
Analytical Procedure Lifecycle Management
Data governance in a regulated laboratory
ICH Q12
USP <1220>
ECA APLM guideline
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 - Linear regression; Correlation Coefficient & Coefficient of Determination
Exploration of more sophisticated statistical techniques such as interval hypothesis testing and experimental design
Robustness and Ruggedness: the Pathway 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 Lifecycle
Product Development Life Cycle
Sources of Guidance
ICH Q14 Concept paper
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
Comparison of the APLM and Current ICH & USP Approaches
Traditional approach to analytical method (procedure) validation, verification and transfer - ICH Q2 - USP <1225> & <1226> [& <1224>]
FDA process validation guidelines 2011
USP initiatives: Application to analytical processes
Proposed General Chapter <1220>
Statistical toolbox for<1225>; General Chapter <1210>
New ECA AQC Guideline
Analytical Procedure Lifecycle Management
New ICH initiatives
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. Validation Documents Critique The participants will work, in detail, on a typical case study proposing a suitable program of work for a validation dossier. Method Transfer The participants will discuss practical details of an Analytical Methods Transfer.
This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager" Learn more
Testimonials
Seminar Programme as PDF