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 9, 2025
Pharmaceutical Compliance and Product Quality 1. Pharmaceutical Compliance Definition:Adherence to all applicable laws, regulations, guidelines, and internal SOPs that govern pharmaceutical manufacturing, testing, storage, and distribution. Key Compliance Areas: GMP...
by Dr. Yashashwini Reddy | Aug 9, 2025
Out of Specification (OOS) Investigation in Pharmaceuticals Definition OOS results are test results that fall outside the pre-established acceptance criteria defined in specifications, procedures, or regulatory filings.They can occur in raw materials, in-process...
by Dr. Yashashwini Reddy | May 19, 2025
A Systematic Investigation of Out-of-Specification (OOS) Results in Analytical Testing is a structured approach to identify, evaluate, and resolve instances where test results fall outside predefined specifications. This process is vital in pharmaceutical quality...
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...
