Auditing | Assessing the Quality Systems and Records

Supplier Audits

Area: Great Los Angeles Area
Project Type: Auditing

About this Project

OBJECTIVE

Auditing services from PSC for over the past 7 years.

SERVICES

This client utilizes PSC® Biotech’s professional services group to perform Supplier Audits. PSC Biotech® auditors focused the majority of audit time observing the “on the floor” operation at the vendor site. The auditors assess the quality systems and records to assure that the materials produced are made in compliance with current Good Manufacturing Practice standards for foods, drugs, biologics or devices and to determine if the vendor operates in a “state of control”. The PSC Biotech® Services Project Manager and Supplier Auditors worked with the clients Quality team to assure that the clients specific quality concerns were incorporated into the supplier audit items and process.

EQUIPMENT USED

“FPC50W – Isolator (Watson Marlow-Ziel)
FlexPro 50 – Isolator (Groninger – Ziel)
Steris Autoclave (27 cu ft. production)
Santimatic COP washer
Seidnator (2)
Innova Deneste
USP water, Pure steam, Compressed air, Nitrogen, AHUs, Water for Injections. -Not tools used

PROJECT SUCCESS

For each project, PSC® appointed a Project Manager and 3 Senior Supplier Quality Auditors who successfully developed and maintained a supplier audit schedule in consultation with the client quality; scheduled audits with vendors and provided reports to the clients quality of the status of all audits identified, audits planned, audits executing, reports issued, vendor audit response and corrective and preventive action follow-up status and audit closeout.