Regulatory Expectations for Analytical Method Development in Pharma

Regulatory Expectations for Analytical Method Development in Pharma

Regulatory agencies like the FDA, EMA, and ICH have set stringent guidelines for analytical method development to ensure drug safety and efficacy. Compliance with these regulations is critical for pharmaceutical...

Validation vs. Verification: Ensuring Accuracy in Analytical Methods

Validation vs. Verification: Ensuring Accuracy in Analytical Methods

When developing analytical methods for pharmaceuticals, two critical aspects must be considered—validation and verification. While both ensure the accuracy and reliability of analytical techniques, they serve distinct purposes. Understanding their...

Step-by-Step Guide to Analytical Method Development for Pharmaceuticals

Step-by-Step Guide to Analytical Method Development for Pharmaceuticals

Analytical method development is a critical aspect of pharmaceutical research and quality control. It ensures the accurate identification, quantification, and characterization of drugs and their components. A well-developed analytical method...