by Dr. Yashashwini Reddy | Aug 9, 2025
Common Causes of Low Quality in Pharmaceuticals Ensuring high-quality pharmaceuticals is crucial to patient safety, regulatory compliance, and brand reputation. Low-quality products can lead to therapeutic failure, adverse reactions, and recalls. The following are...
by Dr. Yashashwini Reddy | Aug 9, 2025
Non-conformance in Pharmaceuticals Definition:Non-conformance refers to any deviation from established standards, specifications, regulatory requirements, or approved procedures in the pharmaceutical manufacturing, testing, or distribution process. Examples of...
by Dr. Yashashwini Reddy | Aug 8, 2025
5 Why Tool – Overview The 5 Why Tool is a simple but powerful problem-solving method used to identify the root cause of an issue by repeatedly asking “Why?” until the underlying reason is found. Typically, five iterations of “Why” are enough to reveal the true root...
by Dr. Yashashwini Reddy | May 7, 2025
Standard Operating Procedure (SOP) 1. Objective To establish standardized procedures for reprocessing and reworking pharmaceutical products to ensure that all batches meet predefined specifications and maintain product quality. 2. Scope...
by Dr. Yashashwini Reddy | May 7, 2025
SOP for Failure Investigation in Pharmaceutical Manufacturing Here’s an overview of the Standard Operating Procedure (SOP) for Failure Investigation in pharmaceutical manufacturing, focusing on identifying root causes, implementing corrective and preventive...
