The Quality Assurance Department (QA) is commonly referred to as Documentation Control. QA manages and maintains all master production and control records, standard operating procedures, forms and packaging records. Quality Assurance assigns lot numbers for new orders and issues working copies of the batch records to the manufacturing department. QA is responsible for the review of production records to assure documentation completeness and cGMP compliance. This department is also responsible for the maintenance of the stability program and the review of lab data for product release decisions.
Label Control is an extension of the QA department and is responsible for labeling review, approval, issuance, and reconciliation of labeling at the completion of a packaging process.
