What is qc dossier?

A QC (Quality Control) dossier is a comprehensive document that contains all the essential information and data related to the quality control processes of a pharmaceutical product or a manufacturing process. It typically includes details on raw materials, analytical methods, validation studies, stability data, and compliance with regulatory standards. The dossier serves as a critical resource for ensuring product quality, consistency, and safety throughout the product lifecycle, and is often required for regulatory submissions.