Statistical Tools for Analytical Procedures based on USP

  • December 6, 2018
    9:00 am - 5:00 pm


15 Allstate Parkway, Suite 600, Markham, Ontario, Canada, L3R 5B4

Certification Areas

The USP General Chapter <1210> on Statistical Tools for Procedure Validation is the “tool belt” that you need for your analytical procedure qualification (validation). You can use the statistical tools to guide your analytical procedure development, your procedure qualification and the continued use of your procedure. This course will review these tools in detail with examples.

One such tool is the tolerance interval. It can demonstrate if the method you have developed or transferred into your lab will meet your requirements not only during qualification or transfer, but throughout its use. Another tool is the confidence interval that can tell you the likely potency of a lot of drug product.

A brief introduction to measurement uncertainty will be provided. Target Measurement Uncertainty is a key part of the lifecycle of an analytical procedure. Learn how you can determine your target.


Approach to Training

The course is designed to be interactive. After a concept is taught, the attendees will apply it to an example. By the end of the course, people will have worked through a complete example. The example could be based on a product or method from your operation if you are able to bring the data to the course.

Bring your computer

It is best that you bring your computer to the workshop so you can use the spreadsheets that will be distributed with this course.  


Proposed Agenda

How to set acceptance criteria


  • Decision Rule

o   What a decision rule is

o   Different types of decision rules

o   Probability in the decision rule


  • Measurement Uncertainty

o   What measurement uncertainty is

o   Introduction to USP PF  44(1) Stimuli to the Revision Process: Measurement Uncertainty for the Pharmaceutical Industry

o   Brief introduction on how to evaluate measurement uncertainty

o   Where measurement uncertainty is used in fitness for use and in the statistical tools of USP


  • Setting the Target Measurement Uncertainty (TMU)

o   The TMU becomes part of the Analytical Target Profile (ATP)

o   The ATP states the goal for analytical procedure development and subsequent qualification


  • Example

o   The participants will work through an example

  • Develop the decision rule
  • Calculate the target measurement uncertainty
  • Write the analytical target profile

USP <1210>

  • companion to Validation of Compendial Procedures 〈1225〉 with the purpose of providing statistical methods that can be used in the validation of analytical procedures

o   terminology

o   what to do before validation, procedure development

o   how to decide which ruggedness factors to include in experiments

o   accuracy & precision

o   Combining Accuracy & precision

  • Why this is better than considering accuracy and precision separately
  • Prediction interval
  • Tolerance interval

o   Limit of Detection (LOD) and Limit of Quantitation (LOQ)

  • Example

o   The participants will work through an example

  • Calculate the tolerance interval
  • Calculate the LOD
  • Calculate the LOQ


  • Overview of USP <1010>

o   This chapter provides information regarding acceptable practices for the use of analytical procedures to make decisions about pharmaceutical processes and products.

  • Basic statistical principles
  • Statistical study
  • Comparison of two analytical procedures
  • Control charts

o   Brief description

o   Where and when to use them in the control strategy

  • Measurement principles
  • Outliers
  • Example

o   The participants will apply some of these statistical tools and concepts to the example analytical procedure


SPEAKER: Jane Weitzel

Jane Weitzel has been working in analytical chemistry for over 40 years for pharmaceutical and mining companies.  She is currently a consultant specialising in laboratory management systems and ISO/IEC 17025, an auditor, and an educator. Jane has applied Quality Systems and statistical techniques, including the evaluation and use of measurement uncertainty, in a wide variety of technical and scientific businesses. She has obtained the American Society for Quality Certification for both Quality Engineer and Quality Manager.


For the 2010 – 2015 cycle, Jane was a member of the USP Reference Standards committee and Expert Panel on Method Validation and Verification. In 2014 she was pointed to the Chinese National Drug Reference Standards Committee and attended their inaugural meeting in Beijing. Jane is a member of the USP’s Expert Committee on Statistics and the Expert Panel on Method Validation and Verification For the 2015 – 2020 cycle.



Student Ticket: $250.00 Sold Out
Basic Non-Member Ticket: $700.00 Sold Out
Group Tickets (5+): $605.00 Sold Out
Pro/Pro Plus Member Ticket: $625.00 Sold Out