919-827-0933 info@manganbio.com

Client:

  • Major Global Pharmaceutical Corporation

Project Duration:

  • 12 months

Overview:

  • Mangan was contracted to provide integrated Commissioning and Qualification services for a large pharmaceutical manufacturing facility, located in the Eastern USA
  • Scope included:  Clean Utilities, Room Qualification through Environmental Monitoring Performance Qualification, Production and ancillary equipment C&Q, and Media Fills.
  • C&Q activities spanned from installation and start up through Performance Qualification.

Strategy:

  • A dedicated team of Mangan personnel worked with site staff and other contract resources to develop System and Testing documentation, execute protocols, investigate failures, and develop summary reports.
  • A Mangan representative provided project leadership, prioritization, resource management and progress reporting to client personnel.

Process:

  • A matrix of project deliverables was created categorizing by deliverable type, due date, and complexity.  The matrix was maintained up to date and expanded to include phases (in review, approved, in execution, post review, complete)
  • Resources were scheduled for 24/7 coverage during critical project phases to maintain timelines and ensure a timely project delivery.
  • Twice daily meetings were used to communicate issues with the potential to impact the project timeline and present possible corrective actions.  Site resource needs were communicate during this meeting to representatives of Operations, Engineering, and Quality.

Result:

  • Mangan personnel were able to successfully deliver the project and continue to support the site with additional projects and on going qualification support.