by Dr. Yashashwini Reddy | Nov 28, 2024
Out of Specifications (OOS) in Pharmaceuticals Out of Specification (OOS) results occur when the test results of a pharmaceutical product fall outside the predefined acceptance criteria specified in regulatory guidelines or quality standards. These deviations are...
by Dr. Yashashwini Reddy | Nov 28, 2024
Why Data Integrity Matters in Pharmaceuticals: Insights from Patients and Regulators In pharmaceuticals, “data integrity” ensures data remains accurate, consistent, and reliable throughout its lifecycle. It forms the backbone of quality assurance in...
by Dr. Yashashwini Reddy | Nov 1, 2024
Importance of Critical Process Parameters (CPPs) in Pharmaceutical Manufacturing Critical Process Parameters (CPPs) are key to ensuring product quality in the pharmaceutical industry. These parameters—such as temperature, pH, mixing speed, and pressure—are closely...
by Dr. Yashashwini Reddy | Oct 27, 2024
Ensuring Quality in Tablet Manufacturing: The Essential Role of Critical Quality Attributes (CQAs) Introduction In the pharmaceutical industry, ensuring the consistent quality, safety, and effectiveness of products is non-negotiable. Tablets, one of the most common...
by Dr. Yashashwini Reddy | Oct 27, 2024
The Critical Role of Critical Quality Attributes (CQAs) in the Pharmaceutical Industry Introduction In the pharmaceutical industry, ensuring product quality and patient safety is paramount. Critical Quality Attributes (CQAs) are essential to maintaining these...
