Practical Statistical Tools for Analytical Laboratories Performance Evaluation and Monitoring for compliant Analytical Procedures and Processes
Course No 21261
This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager". Learn more.
This course includes an optional free pre-course webinar “Statistical Simulations for Enhanced Understanding of Analytical Performance” on Monday, 09 September 2024 from 14.00 – 16.00 CEST. The participants will receive an Excel file with simulation worksheets, which will be explained in the webinar and which can be used later for own applications. If you are unable to attend the live webinar
Dr Christopher Burgess, Burgess Analytical Consultancy, UK Dr Joachim Ermer, Ermer Quality Consulting, Germany
Statistical calculations and tools are applied extensively in pharmaceuticalanalysis including
Procedure development and validation
Transfer of analytical procedures
Setting or verification of specification limits
Data evaluation, comparison and trending
The ICH Q10 Guideline “Pharmaceutical Quality System”, the FDA Guidances on Process Validation and Methods Validation require monitoring of “process performance and product quality” and “Trend analysis on method performance” throughout the product lifecycle. The new ICH guidelines Q2 Validation of Analytical Procedures (Revision 2) and Q14 Analytical Procedure Development request the use of “appropriate statistical methods” to evaluate calibration functions, precision, and accuracy, for example by regression analysis, confidence, prediction, and tolerance intervals. Hence the appropriate use of statistical trending and evaluation tools has become mandatory.
Consequently, a thorough understanding of statistical fundamentals is essential in order to be able to select parameters and test methods that are ‘fit for purpose’.
Do you speak statistics?
In addition, such an understanding facilitates the communication with other technical and regulatory functions applying statistical tools in order to ensure an overall consistent approach.
The course will provide the participants with recommendations, tools and examples to apply scientifically and pragmatically sound statistical principles to their day-to-day business as well as to meet future challenges described above.
The relevance of such statistical tools is also increasingly recognised by the Compendia, as reflected, for example, in the USP General Information Chapter <1010> “Interpretation and treatment of analytical data” and the recently introduced <1033> “Biological assay validation” together with the General Chapter <1220> on Analytical Procedure Lifecycle.
Statistical tools are needed, for example, to evaluate:
Distribution of data and its parameters
How to detect outliers and trends?
How to establish the total variability of the method?
How to identify method parameters that must be controlled?
Method performance and specification limits - Which accuracy and precision is needed to achieve an acceptable risk of OOS results? - Scientifically based justification and optimisation of the reportable result (single or average?) - What are the requirements for impurity methods?
Comparison of methods and data
What are the requirements for calibration models?
How to optimise the number of calibration replicates on a scientific Basis?
A brief discussion of supporting software tools (e.g. Excel, Minitab, JMP) to facilitate the generation of statistical information in a consistent manner will be undertaken.
One of the main features of this course is the balance of presentations and more than four hours of practical exercise workshops which will allow participants to gain ‘hands on’ practical experience in applying the statistical methods described. By means of statistical simulation tools, the participants will gain intuitive understanding of the consequences of appropriate and inappropriate performance parameters, for example the relationship between precision and OOS results.
For this reason, the course is limited to 30 participants so that individual attention and support can be given. In order to fully benefit from the workshops, attendees should preferably bring a notebook with Excel® 2007 or later.
This best practice oriented course is designed for analytical laboratory managers and their colleagues charged with the day to day management and evaluation of laboratory data throughout the lifecycle, i.e. in method development, validation, transfer, specification setting, batch release and stability, continuous performance verification and change control.
QA, manufacturing and regulatory affairs professionals will benefit from participation by gaining a clear understanding of the statistical fundamentals which are important to implement scientifically sound and pragmatic tools to conform to GMP and regulatory requirements for example Product Quality Review.