by Dr. Yashashwini Reddy | Sep 6, 2025
Data Falsification in the Pharmaceutical Industry 1. What is Data Falsification? Data falsification in pharmaceuticals refers to the intentional manipulation, fabrication, or misrepresentation of data in order to conceal deviations, meet specifications, or mislead...
by Dr. Yashashwini Reddy | Sep 6, 2025
Importance of Data Integrity for Pharmaceutical Regulatory Agencies 1. What is Data Integrity? Data integrity means maintaining the accuracy, completeness, consistency, and reliability of data throughout its lifecycle, ensuring it is attributable, legible,...
by Dr. Yashashwini Reddy | Sep 6, 2025
The Importance of FDA Form 483s and Warning Letters in Pharmaceuticals 1. What is FDA Form 483? FDA Form 483, “Inspectional Observations,” is issued by FDA inspectors to company management at the end of an inspection. It lists potential violations of the Food, Drug,...
by Dr. Yashashwini Reddy | Sep 6, 2025
How to Review GMP Documents Like a Pro 1. Understand the Purpose of the Document Identify the type: SOP, Batch Manufacturing Record (BMR), Protocol, Validation Report, Logbook, etc. Ask: What is this document supposed to control, guide, or prove? 2. Verify Structure...
by Dr. Yashashwini Reddy | Sep 6, 2025
Current Good Manufacturing Practices (cGMP) in Pharmaceutical Industries Current Good Manufacturing Practices (cGMP) are the regulatory standards enforced by agencies like the USFDA, WHO, and EMA to ensure that pharmaceutical products are consistently produced and...
