Analytical Method Validation for Cleaning Validation Residues

 

 

Instructor: Richard Forsyth

This Web Seminar will present a detailed overview of analytical method validation for cleaning validation swab samples for Active Pharmaceutical Ingredients (APIs) and detergents from product contact surfaces of equipment in the pharmaceutical industry. All phases of method validation: validation parameters, regulatory expectations, designing the method, designing the method validation protocol, instrumentation, method validation execution and method transfer will be discussed with the emphasis on the unique challenges and opportunities for a cleaning validation program.

Current regulatory expectations and how they impact analytical method validation will be reviewed. Of note will be the expectations for quantitative tests versus limit tests.

The validation parameter phase evaluates the parameters necessary to clearly demonstrate that an analytical method will accurately and consistently provide data that demonstrates a cleaning validation study is successful.  The validation parameters are evaluated individual to assess their impact on the method validation.  The calculated cleaning limit directly impacts the validation parameters to be validated.

The validation parameter of swab recovery will be reviewed more closely, since it is particular to cleaning validation studies. Examples of recovery studies will be provided for clarification.

The method development phase takes the validation parameters and develops a cleaning method based on the physical properties of the API or detergent, a thorough evaluation of the capabilities of the instrumentation, and the sensitivity of the instrument detector. Method development optimizes the validation parameters to a level that assures successful analytical method.

The method validation phase will provide documented evidence through an executed protocol which provides a high degree of assurance that the analytical method consistently removes tests cleaning validation samples down to levels below the pre-determined acceptable levels and the method system suitability parameters can provide ongoing assurance that the analytical method remains in a state of control.

Validation pitfalls are reviewed to point out potential issues to avoid them rather than fall victim to simple errors.  Pitfalls reviewed go beyond the method to include quality systems and other facility and documentation issues.

Instrumentation options are reviewed including the pros and cons of each approach.

Teaching objectives for this presentation include:

• Regulations
• Validation Parameters
• Swab recoveries and techniques
• Designing the Method
• Designing the Method Validation
• Designing the Validation Protocol
• Instrumentation
• Execution
• Transferring Methods

Fee:
$385 for one person
$700 2-5 people
$999 6-10 people

 

 

Questions? support@eccwebinars.com

ECC-092