It's What We Do
It's What We Do
CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.
Compounded sterile products are not FDA-approved, requiring thorough audits of outsourcing facilities to ensure cGMP compliance. Following the 2012 fungal meningitis outbreak New England Compounding Center, outsourcing facilities face increased regulatory scrutiny for their products.
PAC Auditing Solutions conducts comprehensive cGMP compliance audits at US outsourcing facilities. Our site audits evaluate quality management systems in accordance with FDA's current Good Manufacturing Practices for Human Drug Compounding.
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