A North American client contracted KPC International to develop a C&Q and Operational Readiness strategy for the start-up of their $300 million API facility across all client departments. Upon completion of this strategy, KPC was engaged to provide Commissioning, Qualification, and Validation Document Generation and Execution services.

Project Scope

The services by KPC on this project included:

  • Integrated Operational Readiness workshop across all client disciplines – Operations, Engineering and Maintenance, QA, QC, HR, and Organisational Development
  • Production of a detailed start-up strategy for each department which were integrated into an overall strategy for the department
  • Development and oversight of a Tech Transfer strategic framework including PMO tools, resource loaded schedule and SOP’s
  • Development of an integrated C&Q strategy incorporating client Operations personnel
  • Generation of Test Documentation remotely and establishment of a Time Critical Document Review and Approval Process
  • Management and oversight of the execution of the C&Q activities
  • Development of a bespoke Earned Value Monitoring System to track progress against baseline
  • Established a Standard Guidance Document (PMO Handbook) to create oversight structure for Senior Management for site projects to ensure alignment to strategic plans, financial plans, resourcing plans and development
  • KPC also established a Project Review Forum and a PMO process

To learn more about our Commissioning, Qualification, and Validation services for the Pharmaceutical and Biotech industries, visit our services page here, or get in touch directly with Global head of CQV Operations Paul Fitton at [email protected]