by Dr. Yashashwini Reddy | Apr 20, 2025
Standard Operating Procedure (SOP) 1. Purpose: To establish a standard procedure for the sampling, testing, and quality assessment of finished products before their release for distribution or sale. 2. Scope: This SOP applies to all finished products...
by Dr. Yashashwini Reddy | Dec 1, 2024
Classification of GMP Deficiencies: A Comprehensive Guide for Pharmaceutical Compliance Good Manufacturing Practice (GMP) is a cornerstone of pharmaceutical manufacturing, ensuring that products are produced and controlled according to rigorous quality standards....
by Dr. Yashashwini Reddy | Nov 28, 2024
Out of Specifications (OOS) in Pharmaceuticals Out of Specification (OOS) results occur when the test results of a pharmaceutical product fall outside the predefined acceptance criteria specified in regulatory guidelines or quality standards. These deviations are...
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 | Nov 27, 2024
Interview Questions and Answers on Module 3.2.P (Drug Product) Under Quality – CTD 1. What is the 3.2.P section of the CTD? Answer: The 3.2.P section in Module 3 of the CTD deals with the drug product. It provides detailed information about the finished dosage...
