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Auditing – Quality Systems And Records – PSC Biotech

About this Project

OBJECTIVE

Perform Supplier Audits in compliance with current Good Manufacturing Practice standards for Drugs, Biologics and Devices. 

SERVICES

This client utilizes PSC® Biotech’s professional services group to perform Supplier Audits. The main focus was to assess the quality systems and records to assure that the materials produced are made in compliance with current Good Manufacturing Practice standards for Drugs, Biologics and Devices to determine if the operation is in a “state of control”. The PSC Biotech® Services Project Manager and Senior Supplier Auditor worked with the client’s Quality team to ensure that the client’s specific quality concerns were incorporated into the supplier audit items and process. This client utilizes PSC® Biotech’s professional services group to perform Supplier Audits. The main focus was to assess the quality systems and records to assure that the materials produced are made in compliance with current Good Manufacturing Practice standards for Drugs, Biologics and Devices to determine if the operation is in a “state of control “. The PSC Biotech® Services Project Manager and Senior Supplier Auditor worked with the clients Quality team to assure that the clients specific quality concerns were incorporated into the supplier audit items and process.

PSC® appointed a Project Manager and a Senior Supplier Quality Auditor who successfully developed and maintained a supplier audit schedule in consultation with the client quality team. Audits were scheduled with vendors and executed as planned. Audit reports were issues, audit responses and corrective action and preventive action follow-up status and closeout reports were provided to the client.

PROJECT SUCCESS

The project was a success, and the company is still a client of PSC®.