Pharmaceutical Analysis Blog

Principles of HPLC Validation - Training Module 2: Method Development and Pre-Validation

A short course in the systematic validation of HPLC methods. The validation process is best started with the first injection during method development. We discuss the importance of having an overall plan for the method development / validation / method application life cycle.

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:

The validation process is best started with the first injection during method development. We discuss the
importance of having an overall plan for the method development / validation / method application life cycle. A brief overview of method development is given (see Advanced HPLC Method Development for details on method development). The importance of pre-validation is emphasized along with key tests that should be undertaken. No method is complete without a well designed system suitability test, so we discuss what is appropriate for this.

  • The Plan 
  • Pre-Validation 
  • System Suitability

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 should you put together a validation plan before beginning the validation process?
  • Why should you go through a pre-validation process before the actual validation?
  • Why is it a good idea to specify an equivalent column in the method documentation?
  • Why is a system suitability test needed?
  • Which of the following performance parameters are required for system suitability?

 

Principles of HPLC Validation - Available at USD98 Validate HPLC methods for  the analysis of pharmaceutical drug substance, drug product, impurities, and  degradation products.

 

    

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