Understanding The Role Of The Quality Unit In Good Manufacturing Practices

The quality unit is an independent department, fulfilling quality assurance (QA), sterility assurance (SA) and compliance responsibilities. Quality control (QC), while it often functions as an independent department, is closely linked to the work of the quality unit. The QC team will evaluate the performance and adherence of materials throughout the manufacturing process; it also evaluates the facility, equipment and laboratory processes that govern operations. The quality unit and QC team work together to ensure the proper functioning of the Quality Management System (QMS).

This blog reviews the specifics of a QA team, SA team, compliance team, and QC team. The many functions that the quality unit oversees in a GMP facility are also outlined.