The Quality Assurance Department (QA) is responsible for managing and providing oversight for the quality systems at Sovereign Pharmaceuticals. Each batch manufacturing cycle begins and ends with QA, but depends on each department following the quality systems and maintaining cGMPs to produce quality products. QA issues the manufacturing lot numbers and the appropriate record, reviews/approves each executed record, the analytical data and stability reports.
Based on these documents QA makes the final disposition decision for each component, raw material, and drug product. QA has the primary responsibility of managing and maintaining master documents such as: manufacturing records, packaging records, analytical procedures, specifications, and SOPs. Additionally, QA maintains original data generated from the master documents. To facilitate these functions QA is organized into groups for Component Release, Document Control, Label Control, In-process Inspections, and Production Release. To facilitate company compliance with cGMPs, QA provides ongoing training and assists in new employee orientation.