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....
by Dr. Yashashwini Reddy | Mar 30, 2025
Module 3: Quality (CMC) in Regulatory Dossier Submission In pharmaceutical regulatory submissions, Module 3 of the Common Technical Document (CTD) plays a critical role in ensuring drug quality, safety, and efficacy. This module, also known as the Quality Module,...
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....
