Which department in a biopharmaceutical company has the final say if a production batch may be released for sale or use?

In a biopharmaceutical company, the department responsible for determining if a production batch can be released for sale or use is Quality Assurance. This department plays a critical role in ensuring that all products meet the required standards for quality, safety, and efficacy before they reach consumers.

Quality Assurance is tasked with establishing and maintaining robust systems of oversight to confirm that all manufacturing processes comply with regulatory guidelines and internal quality protocols. They are involved in the assessment of production batches, conducting necessary evaluations, and ensuring that documentation is in order. Their decision is based on pre-defined criteria and standards, ensuring that any product released does not pose risks to patients or end-users.

While Research and Development focuses on developing new products, and Production is involved in the actual manufacturing processes, neither department has the authority to approve a batch for release without the oversight of Quality Assurance. Regulatory Affairs, on the other hand, ensures compliance with laws and regulations, but the final decision for release rests with Quality Assurance, which is directly responsible for product quality.