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...
by Dr. Yashashwini Reddy | Oct 18, 2024
Understanding the Difference Between Out of Trend (OOT) and Out of Specification (OOS) in Pharmaceuticals In the pharmaceutical industry, maintaining product quality and regulatory compliance is critical. Two key terms often encountered in quality control are Out of...
by Dr. Yashashwini Reddy | Oct 10, 2024
Unveiling the Role of the Analytical Quality Assurance (AQA) Department in Pharma In the world of pharmaceuticals, quality is everything. That’s where the Analytical Quality Assurance (AQA) department steps in, ensuring that every drug produced meets strict...
