PAC Auditing Solutions 1055 Howell Mill Rd, Suite 800, Atlanta, GA 30318
cGMP Auditing
That's What We Do
cGMP Auditing
That's What We Do
cGMP Auditing
That's What We Do
cGMP
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.
Regulatory bodies (FDA), accreditation agencies (ISO, JCAHO, DNV), and payment insurers (CMS) all require that suppliers are audited/evaluated when purchasing product. Due to the fungal meningitis outbreak of 2012 at New England Compounding Center, there is more scrutiny surrounding products purchased from Outsourcing Facilities. Compounded products are not approved by FDA, and therefore, facilities that supply compounded product should be audited to confirm cGMP compliance.
PAC Auditing Solutions performs good manufacturing practice audits at outsourcing facility sites in the US to confirm cGMP compliance. We carry out full site audits that focus on the facility’s quality management systems as they relate to current Good Manufacturing Practice — Draft Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.
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