Pharmaceutical Analysis Blog

Principles of HPLC Validation - Training Module 3: Validation and Documentation

A short course in the systematic validation of HPLC methods. We go through the various validation steps in detail. We review the key regulatory requirements from the International Committee on Harmonization (ICH), which also apply to the national pharmacopoeial organizations (USP, EP, BP, JP).

This course is designed for laboratory personnel responsible for validating HPLC methods. It will also be useful for managers and quality assurance staff involved in the method validation process. For workers who develop, but do not validate methods, this class will give insight into how to develop methods that will be easier to validate. No prior experience is needed, although those with some laboratory experience will certainly benefit more than those with no experience at all.

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This course covers:

In this section, we go through the various validation steps in detail. We review the key regulatory requirements from the International Committee on Harmonization (ICH), which also apply to the national pharmacopoeial organizations (USP, EP, BP, JP). To illustrate the outcome of validation, we review the results of a drug potency method validation and one for related substances.

  • The Validation Process
  • Regulatory Requirements – Part I 
  • Regulatory Requirements – Part II
  • An Example

By attending this online training course you will understand how to organize a validation project. By planning ahead, you will see how to develop better methods that will validate more easily and will function more reliably in routine use. You will realize how by using Quality by Design principles during development, the methods will be easier to validate and be more robust in routine use. You will learn how to decide which variables are important and which ones are not. You will see how software tools can help you to get much more mileage out of your experimental runs. You will gain a better understanding of the calibration process and how to examine data for problems. Learn when method adjustments are allowed without re-validating the method. Find out why uncertainty plays such a big role in validation.

You will be able to answer these questions upon completion of the course

  • Why is a validation protocol required?
  • What are the characteristics of ICH method validation?
  • What is the term method performance means according to the ICH?
  • What is the purpose of demonstrating specificity for a method?
  • What is the range of an analytical method?
  • What is robustness?
  • What is linearity?
  • Describe the method range that needs to be demonstrated during validation?
  • Why should accuracy be demonstrated by comparing the proposed HPLC method to another analytical procedure?
  • Why would you want to demonstrate the reproducibility of a method?
  • Describe the testing a method for accuracy of impurity measurements?
  • Describe the performance of a method that must be demonstrated at the detection limit (LOD, DL)?
  • Describe the performance of a method at the quantitation limit (QL, LOQ)?
  • Describe the validation process?

 

Principles of HPLC Validation - Available at USD125 Validate HPLC methods for  the analysis of pharmaceutical drug substance, drug product, impurities, and  degradation products.

 

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