Outsourced Manufacturing Suppliers and Quality Regulatory Audits

Recently I was asked by pharma, how can we ensure that outsourced suppliers are manufacturing product in accordance and compliance with FDA regulations. FDA regulations are clear, whether for drug, device, biologic, vaccine, other, pharma is ultimately responsible for the quality of their product. FDA has new regulations pertaining to quality manufacturing activities (and a new Commissioner) and thus, the industry will be scrutinzed regarding increased regulatory, quality rigor, focused on enforcement of high standards of manufacturing and operations.

What can you investigate before choosing your outsourced supplier for your manufacturing needs:

• audit and evaluate business practices and standard of operations
• audit and evaluate quality, management and manufacturing systems, in process checks
• audit and ask about records, procedures, validation, maintenance, calibration, traceability, processes
• audit and review procedures that address actions for non-conforming product and standard deviation
• audit and investigate history of product release, training, customer track record, pharma satisfaction, FDA satisfaction/correspondence, complaint actions and responses
• audit contracts.

Quality should not be predicted. Quality should be evident by audit. Choose your outsourced manufacturer by audit to ensure quality and adherence to FDA regulations and guidance.