by Dr. Yashashwini Reddy | Apr 30, 2025
The practice of calibrating dissolution testers with salicylic acid tablets was discontinued for several reasons: Inconsistent Results: Salicylic acid tablets showed variations in their dissolution profiles, which could result in inconsistent and unreliable...
by Dr. Yashashwini Reddy | Apr 29, 2025
System suitability in High-Performance Liquid Chromatography (HPLC) analysis is a set of tests conducted to ensure that the HPLC system is performing optimally for the specific analysis being performed. These checks help determine if the system is capable of producing...
by Dr. Yashashwini Reddy | Apr 29, 2025
Quality issues in the pharmaceutical industry can arise from a variety of sources across the entire lifecycle of drug development, manufacturing, and distribution. Below is a detailed breakdown of the root causes: 1. Manufacturing Process Failures Inadequate Process...
by Dr. Yashashwini Reddy | Apr 29, 2025
Analysis of Out of Specification (OOS) Occurrences in Pharmaceutical Products In the pharmaceutical industry, the term Out of Specification (OOS) refers to situations where the results of tests or measurements fall outside the predefined limits or specifications set...
by Dr. Yashashwini Reddy | Apr 29, 2025
The essential GMP (Good Manufacturing Practice) compliance requirements for pharmaceuticals are designed to ensure the consistent production of high-quality, safe, and effective medicinal products. These requirements are globally recognized and enforced by regulatory...
