CASE STUDY
A large Drug/Pharma Contract Manufacturing Organization (CDMO) selected RCM to provide a solution to their Quality Control (QC) Equipment Validation challenges.
OBJECTIVE
A large Drug/Pharma Contract Manufacturing Organization (CDMO) selected RCM to provide a solution to their Quality Control (QC) Equipment Validation challenges. This high priority project required RCM to perform a risk assessment on equipment, report and discuss findings, develop a project plan that addressed issues, and execute to plan. RCM’s team was required to qualify / validate / move / decommission / calibrate 50+ pieces of equipment.
SOLUTION
RCM’ s Role:
- Assess and develop QC Equipment Validation Project Plan
- Provide certified resources
- Perform tasks based on type of equipment and identified action
- Work independently with minimal company involvement
- Manage the project from inception to completion
- List of Tasks:
- GCC Generation and completion of change control documentation
- Equipment IQ/OQ/PQ Protocols Development, execution and reporting
- SOP’s Development & Training
- Manufacturer IQ/OQ Protocols Execution and Report Generation
- Equipment Calibration
- Maximo/PE Record Updating
- DI Assessment (Prior and After)
- CSV Protocols Development, Execution and Reporting
- EHS Evaluation
BENEFITS
- RCM’s team completed and qualified / validated / moved / decommissioned / calibrated 50+ pieces of equipment
- RCM delivered project on time and budget addressing and eliminating QC validation risks
- Quality Control (QC) Validation Project was successful in addressing the various tasks for new equipment and
- Contract goal of completing the project in six (6) months was achieved.
Key Project Elements
Assessment and Develop QC Validation Project Plan for a large equipment volume of equipment
Address all areas of equipment that needed to be in compliant
Mitigate Risk
Perform training on GMP regulation and QC validation
Complete project on Time and Budget