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
Non-conformance in the pharmaceutical industry refers to deviations from established standards, regulations, or specifications in the production, packaging, labeling, or testing of pharmaceutical products. These deviations can lead to serious consequences, including...
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 28, 2025
Introduction Quality is a cornerstone of the pharmaceutical industry because it directly affects patient safety, therapeutic effectiveness, and public trust. When we talk about “quality standards,” we refer to the strict guidelines, procedures, and...
by Dr. Yashashwini Reddy | Apr 27, 2025
Standard Operating Procedure (SOP) 1. Purpose This SOP defines the procedure for proper collection, labeling, and storage of retained samples of raw materials to ensure compliance with regulatory and quality requirements. 2. Scope This...
