by Dr. Yashashwini Reddy | Aug 12, 2025
How to Write a Validation Protocol A Validation Protocol is a formal, approved document describing how validation will be performed, including the methodology, acceptance criteria, responsibilities, and documentation requirements.It applies to Process Validation,...
by Dr. Yashashwini Reddy | Aug 8, 2025
Why Analytical Method Validation is Required? Analytical Method Validation is essential to ensure that a test method is reliable, reproducible, and suitable for its intended purpose.It is required because: Regulatory Compliance Required by ICH Q2(R1), USFDA, EMA, and...
by Dr. Yashashwini Reddy | Apr 28, 2025
Validating analytical methods is crucial for several reasons, especially in industries where precision, accuracy, and reliability are paramount, such as pharmaceuticals, biotechnology, environmental testing, food safety, and clinical laboratories. Here’s a...
by Srikanth | Mar 28, 2024
What is analytical method validation, and why is it important in pharmaceutical analysis? Can you explain the typical components of an analytical method validation protocol? What are the key parameters evaluated during method validation? How do you determine the...
