Abstract
Poorly defined project goals and an inadequate infrastructure have hindered previous attempts to initiate automation projects in the Novartis Quality Control laboratory. This haphazard approach has been replaced with well-defined project expectations and agreement among the functional groups that make up the project infrastructure to aggressively support the automation project goals.
BACKGROUND
Shortly after the formation of the Novartis Pharmaceutical Corporation in April 1997 the US Quality Control Department formed a small (two-person) laboratory automation group. The team was directed to automate content uniformity and dissolution testing associated with the new company's drug product portfolio.
The group was responsible for all aspects of the program, including:
equipment selection
equipment purchase
equipment validation
equipment calibration
preventive maintenance
repairs
upgrades
re-validation
methods development/validation
change control
instrument/method training
methods transfer
equipment/method support
Over the next three years the Multidose, Multidose Plus and TPW II systems were purchased. However, as a result of the initial and Y2K upgrade validation activities only a small amount of the automation scientist's time was allotted to method related activities and no commercial batches were tested using the equipment.
NEW APPROACH
After a QC department re-organization, the project was moved into the Pharmaceutical Operations Automation (POA) Group. This group is responsible for coordinating all automation projects within the Pharmaceutical Operations Section. This group quickly realized that the project did not have clearly defined/measurable goals and that little or no progress could be made with the allotted resources.
A process mapping exercise was performed to identify the resources needed to support the automation project. Figure 1 shows the flow chart that resulted from this exercise.
Based on the process mapping exercise, it was agreed that the QC Methods Development and Validation (MDV) Group would focus on “value adding” activities. As a result, the group's project responsibilities were narrowed to those listed below.
developing/validating methods
change control
method specific training
method specific support
input into the selection of new automated equipment and projects
The overall project management, equipment purchase and validation activities were assigned to the POA Group. Calibration, PM and repair activities were assigned to the Instrument Support Group.
A project team, composed of one representative from each of the three support groups and the QC-Testing Group, was formed and the project re-started in February of 2001.
PROJECT TEAM
The team quickly defined the project deliverables, objectives and milestones. This process is discussed briefly in the next section. The team meets monthly and provides a forum to discuss project progress, adjusting project objectives and addressing project issues. Two issues that have been addressed include the potential impact the equipment validation activities may have on the ability to develop/validate and transfer methods into the Quality Control Testing Group. The second issue was the long lead times associated with the change controls process required to adopt the automated methods into the testing instructions. In both cases the team was able to identify the critical step in each process, meet with the owner of the step and negotiate solutions that allowed the automation project to move forward while maintaining the integrity of the two processes.
PROJECT DELIVERABLES AND OBJECTIVES
The team agreed that the project deliverable would be the reduction of full time employees (FTEs) required to perform the dissolution and content uniformity test procedures. The project objective (i.e., FTE reduction) was established by determining the direct labor time (DLT) difference between the manual and automated procedures and multiplying the results by the yearly sample throughput for the laboratory. Refer to figures Figure 2–5 below.
Automated dissolution batch DLT Calculation.
Automated dissolution batch FTE Reduction Calculation.
Based on the data, the dissolution and content uniformity test procedures should require seven to eight less FTEs when fully automated.
PROJECT CHALLENGES
Several challenges still faced the automation project. They include:
equipment ownership
technical issues (methods)
security issues (controlled drug products)
equipment capacity
equipment risk
instrument support
future automation strategy/projects
Risk associated with the equipment and instrument support are of immediate concern to the team. Once QC has fully realized the direct labor saving associated with the project it is unlikely that the resources will be available to support manual testing should the automated equipment not be available for an extended period of time. Equipment redundancy and equipment cost are currently being evaluated against extent and impact of the risk. Instrument support has also been identified as being critical to equipment availability and specific actions, such as vendor repair training and appropriately scheduled preventive maintenance procedures are being instituted to minimize equipment down time.
PROJECT STATUS
As a result of having well defined project expectations and representation of the proper supporting functional groups on the project team, the development phase of the project has achieved its 2001 milestone three months early. In addition, the QC-Testing Group has recently started use the equipment for release and stability testing of rug products.
Automated content uniformity batch DLT Calculation.
Automated content uniformity batch FTE Reduction Calculation.