Definition : What is stability studies The ability of a pharmaceutical product to retain its physical and chemical properties within specified limits throughout its shelf life. Types of Stability Studies : Long term testing Stability studies under the recommended storage condition for the re-test period or shelf life proposed (or approved) for labeling. Intermediate testing … Continue reading Guidelines for Pharmaceutical Stability Study →

DEFINATION: New Vendor: Manufacturer identified by Formulation Development or purchase department as a manufacturer to supply of a specific material from a specific manufacturing site. Approved Vendor: Manufacturer of raw material, primary and printed packaging material, which has been approved by QA to supply a specific material from specific site, based on the satisfactory cGMP … Continue reading Vendor Management System in Pharmaceutical Industry →

What is Quality Management system : A Quality management system (QMS) is the core of any quality and compliance process. It is a regulatory requirement that the Food and Drug Administration (FDA) and other global regulatory bodies consider critical. An automated QMS system reduces audit time and findings and lowers the risk of product recalls. … Continue reading Quality Management System (QMS)Importance in Pharmaceutical Industry →