Professional Documents
Culture Documents
90 minute Presentations
SESSION EXAMPLE:
Development and Validation of Analytical Test Methods for Cleaning Samples
I. Selecting a Sampling Procedure
When rinse method is applied
What solvent to select and how that affects your analysis
When swabbing method is applied
Learn importance of swabs selection based on your method
II. Developing and Validating Analytical Methods – Keeping it Simple
Selecting a residue detection method
Setting residue limit acceptance criteria
Modifying your release method for analysis of cleaning samples
Is validation of cleaning analytical method different from API testing?
Conducting and validating recovery studies from different surfaces
How to check if method validation is required for new products
III. Interactive Exercise
Using a real life example, participants study how to develop specific HPLC method for API cleaning samples
and write a validation protocol.
Bonus Material
Example of validation protocol
Relevant articles
Rafail Usatinsky, Ph.D., Analytical Research Manager, Cedarburg Hauser Pharmaceuticals, Inc.