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 — Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.

Once a supplier agrees to an audit, we audit the supplier’s facility and add the audit report to the PAC report library. It may then be accessed by our subscribers. The cGMP audits are conducted by PAC’s qualified and experienced auditors at minimal to no charge to the supplier AND our subscribers never pay for audits.  By subscribing to our service, our subscribers incur a small monthly fee, which represents only a fraction of the costs usually associated with conducting a facility audit. Moreover, the subscriber can receive multiple reports on multiple suppliers in time for accreditation inspections. The subscriber can also request audits for unlisted suppliers, as well as, review regulatory actions for all suppliers in an easy to read format.  Our commissioned audits and audit partnership services can minimize the cost of the audit and ensure that our subscribers receive personalized reports.