by Dr. Yashashwini Reddy | May 19, 2025
A Systematic Investigation of Out-of-Specification (OOS) Results in Analytical Testing is a structured approach to identify, evaluate, and resolve instances where test results fall outside predefined specifications. This process is vital in pharmaceutical quality...
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 Dr. Yashashwini Reddy | Apr 19, 2025
1. What are GLP, GDP, and GMP, and how do they differ? This foundational question tests your understanding of the definitions: GLP: Ensures integrity and quality of non-clinical lab studies. GDP: Ensures data integrity and accuracy in documentation. GMP: Ensures...
by Dr. Yashashwini Reddy | Nov 28, 2024
Why Data Integrity Matters in Pharmaceuticals: Insights from Patients and Regulators In pharmaceuticals, “data integrity” ensures data remains accurate, consistent, and reliable throughout its lifecycle. It forms the backbone of quality assurance in...
by Dr. Yashashwini Reddy | Oct 24, 2024
Good Laboratory Practices (GLP) in the pharmaceutical industry are a set of internationally recognized standards that ensure the quality, consistency, and integrity of non-clinical studies. These practices are critical for ensuring that the data generated during drug...
