About this Project

OBJECTIVE

Commissioning, Qualification, Validation (CQV)

SERVICES

PSC® has been an essential service provider to client throughout the development and implementation of a new cell and gene therapy manufacturing facility. PSC® joined the project during the planning phase and conducted critical design review to ensure facility met cGMP expectations upon completion. Our consultants worked closely with architects, engineers, contractors, and equipment vendors to develop system turnover packages to support subsequent commissioning and qualification efforts. PSC® then performed commissioning and qualification of all facility, utility, and process systems to meet GMP production timelines.

PROJECT SUCCESS

PSC® successfully supported the client’s project to develop a brownfield property into a cell and gene therapy manufacturing facility, performing cGMP operations for clinical trial material production within an aggressive timeline. PSC® partnered with the client and multi-discipline team members throughout the project life-cycle to achieve this success.

About this Project

OBJECTIVE

CQV on sterile fill/finish manufacturing & laboratory facilities.

SERVICES

PSC® provided Commissioning, Qualification, and Validation services for the client’s sterile fill/finish manufactuirng and Quality Control laboratory facilities and utilities.

PROJECT SUCCESS

PSC® provided personnel with both extensive technical writing and validation execution experience to complete initial CQV execution, protocol writing, and report development for this facility start up project.

About this Project

OBJECTIVE

CQV Cleaning Validation Project and Current Decommissioning Project

SERVICES

Corporate initiative to upgrade facility compliance level from cosmetics production to meet regulatory expectations of OTC manufacturing. PSC® initiated work with a site audit to perform a gap analysis and identify compliance deficiencies. Remediation tasks were associated with each of these findings and combined into a WBS structured by compliance streams (e.g. C/Q/V, CAPA, training). PSC® deployed a team of consultants to triage critical issues, and then validation engineers to perform cleaning validation and equipment qualification of all production equipment. 

A dashboard was utilized to manage issues, track status, and communicate progress with site management. Subsequent projects included major facility renovations to resolve structural issues while maintaining ongoing GMP production. PSC® was responsible for managing the mechanical upgrade aspects of the site master plan. PSC® routinely supports facility shutdowns and equipment upgrade projects. Current responsibilities include site decommissioning.

PROJECT SUCCESS

Cleaning validation was completed, including manual cleaning, validated loads in qualified parts washers, and validated automated tank cleaning with qualified CIP system. Equipment qualification was completed. Remediation phase was successfully concluded on schedule and transitioned to routine quality system management with ongoing support from PSC®.