Most Effective Test Method Validation using USP 1225 & ICH Q2 to Avoid warning letters

Overview:

Although the concept of test method validation is based on good science, the expectation that test methods in the pharmaceutical industry be validated was established by the USP in the 1980s and expanded as an international expectation for the industry with the publication of ICH Q2 in the mid 1990s.

Both USP <1225> and ICH Q2 classify test methods employed in the industry into types, based on the intended use and identify the characteristics that must be considered in the validation of each type of method.

In order to perform effective test method validations, the analyst must understand the importance of clearly identifying and understanding the intended use of the test method.  With the understanding of the intended use, the analyst will categorize the test method into one of the types identified in the USP and ICH Q2.  Based on the type of test method and using the guidance in the USP and ICH Q2 the analyst will identify the characteristics that must be considered for effective method validation.

For each characteristic, the USP and ICH Q2 recommend the experiments that the analyst should performed to demonstrate that the method performs as intended.

Why you should attend: The US FDA and other regulatory agencies are critically reviewing test method validations. Observations like: "Failure to establish accuracy, sensitivity, specificity, and reproducibility of test methods employed by your firm", which appear in Warning Letters and 483 observations demonstrate a complete lack of understanding of the regulatory expectations. Other observations that citing to the individual characteristics demonstrate a lack of appreciation for the contributions of the individual method characteristics on adequate method validations. In order to adequately validate test methods, firms must understand the basic terminology associated with test method validation. This webinar will provide an understanding of:

• The types of test methods established by the USP and ICH Q2.
  
  • Assay
  • Identification
  • Testing for impurities – quantitative
  • Testing for impurities – limit
  • Performance
• The characteristics of test methods as defined in the USP and ICH Q2.
  
  • Specificity
  • Accuracy
  • Precision
  • Linearity
  • Range
  • Limit of Accuracy
  • Limit of Detection
• How the characteristics apply to the types of methods described in USP and ICH Q2.
  
• The basics of how to experimentally evaluate the characteristics.

• The requirement for test method validation
  
• The intended use of the test method
  
• Guidance documents covering test method validation
  
• Types of test methods
  
• Characteristics of test methods
  
• Demonstrating the characteristics

• Quality Assurance personnel
  
• Quality Control Managers
  
• Quality Control Supervisors
  
• Quality Control Analysts
  
• Method development Managers
  
• Method development Supervisors
  
• Method Development Analysts