by Naveen kumar | Dec 1, 2024
Classification of GMP Deficiencies: A Comprehensive Guide for Pharmaceutical Compliance Good Manufacturing Practice (GMP) is a cornerstone of pharmaceutical manufacturing, ensuring that products are produced and controlled according to rigorous quality standards....
by Naveen kumar | 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 Naveen kumar | 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 Naveen kumar | 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 Naveen kumar | 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...