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
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
Supplier audits have a significant and multifaceted impact on quality assurance in the pharmaceutical sector. Here’s a detailed breakdown of their influence: 1. Ensuring Compliance with Regulatory Standards Supplier audits help ensure that raw material...
by Dr. Yashashwini Reddy | Apr 29, 2025
Pharmaceutical compliance plays a crucial role in ensuring the overall quality of medicinal products. Compliance in the pharmaceutical industry refers to adherence to regulations, laws, and guidelines set by governing bodies such as the U.S. Food and Drug...
by Dr. Yashashwini Reddy | Apr 13, 2025
The implementation of pharmaceutical isolators in manufacturing is regulated by the Current Good Manufacturing Practices (CGMP) established by the FDA and the EU GMP guidelines, both of which are designed to ensure the quality and safety of pharmaceutical products....
