Quality Control and Quality Assurance: To ensure that pharmaceutical manufacturing facilities comply with regulatory requirements, it is important to establish both quality assurance (QA) and quality control (QC) as separate functions from the approved procedures and regulatory requirement
Facilities and Equipment Manufacturing facilities should be designed, constructed, and maintained with the goal of preventing errors that could impact product safety, quality, or efficacy, such as cross-contamination or mix-ups. Therefore, equipment and utility systems need to be validated, regularly calibrated, and qualified to comply with regulatory requirements.
