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 28, 2025
Validating analytical methods is crucial for several reasons, especially in industries where precision, accuracy, and reliability are paramount, such as pharmaceuticals, biotechnology, environmental testing, food safety, and clinical laboratories. Here’s a...
by Dr. Yashashwini Reddy | Apr 28, 2025
Investigation of OOS (Out of Specification) Results in Analytical Testing In the context of pharmaceutical and biotechnology industries, Out of Specification (OOS) results refer to test results that fall outside the predefined acceptance criteria for a given product...
by Dr. Yashashwini Reddy | Apr 26, 2025
Standard Operating Procedure (SOP) 1. Purpose To define the procedure for the qualification of equipment used in regulated environments (e.g., manufacturing, laboratory, or healthcare) to ensure that it operates as intended, performs...
by Dr. Yashashwini Reddy | Apr 26, 2025
Standard Operating Procedure (SOP) 1. Purpose To define the procedure for the qualification and validation of visual checking inspectors, ensuring that they have the necessary skills and knowledge to accurately perform inspections and meet...
