by Dr. Yashashwini Reddy | Sep 3, 2025
Human Error: Some Fresh Approaches to Consider Human errors are often seen as a root cause in pharmaceutical and other regulated industries, but simply blaming individuals is not enough.Fresh approaches focus on: ✅ System Design – Designing error-proof processes...
by Dr. Yashashwini Reddy | May 5, 2025
Human Error: Some Fresh Approaches to Consider in Production Human error has long been recognized as a significant contributor to accidents, inefficiencies, and quality issues in production environments. However, traditional approaches often place undue blame on...
by Dr. Yashashwini Reddy | Apr 28, 2025
“Factors Contributing to Out-of-Specification Outcomes” refers to the various reasons or elements that can cause a product, process, or system to fall outside the defined limits or specifications. These factors are critical in industries such as...
by Dr. Yashashwini Reddy | May 28, 2024
Departure from an approved procedure, instruction, or documented procedure is called deviation. A deviation should be properly documented and handled. A deviation can occur during the manufacturing, testing, storage, or distribution of pharmaceuticals. Deviations most...
