About this Project
OBJECTIVE
Global auditing assistance from PSC® for over the past two years.
SERVICES
PSC® prepared global auditing tasks for this project which required preparing product audit agendas per the clients document requirements, preparing product auditing, performing CAPA follow-ups, conducting onsite finished product types, writing audit reports, and generating product audit findings and report per the companies document requirements. PSC® has done global auditing for many different facilities for the client. The projects followed the general methodology of quality management system review, facilities and equipment system, materials system, production system, and packaging and warehousing System, and laboratory control system.
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.
PROJECT SUCCESS
The PSC® project team for these auditing tasks included an auditor as well as a lead auditor who traveled on-site to successfully complete projects in accordance with the clients schedule requirements within proposed time frames ranging anywhere from 22 to 63 hours.
