The Pharmaceutical Analyst’s CheatSheet
A Step-by-Step Guide to Validating Analytical Methods for Drug Analysis

Everything you need to tackle your next validation stress-free with confidence and a clear, structured plan.
This free email course gives you everything you need to make your next validation a breeze..
5 simple steps
Tips on proper preparation
Avoid common pitfalls
Clear structured plan easy to follow
My name is Sofie and I worked in the global quality team in one of Germany's biggest Pharma companies with main focus on validations. And now, I want to share everything I know with you.
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Here's everything that's inside:
Step #1: Define the applicable method validation requirements based on current regulatory guidelines to get an overview of what tests and parameters you have to include.Step #2: Develop an analytical method based on similar pharmaceutical drugs and prepare a validation protocol to have a roadmap for your analysis.Step #3: Perform the laboratory work and conduct the validation experiments according to the protocol to generate the raw data for your assessment.Step #4: Analyze and interpret the generated data using statistical methods to evaluate if the acceptance criteria are met.Step #5: Create a comprehensive validation report that presents all results, and it’s evaluation in a clear and understandable manner to have a record of the results with proper justification for the conclusion.