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PHARMACEUTICAL INDUSTRY :
Manufacturing Process Improvement |
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Client: |
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A major generic pharmaceutical company
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Problem: |
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Since the beginning of production, an intermediate product had failed to meet one release specification 6-8% of the time. During certain periods the failure rate increased significantly, which made it difficult for the client to supply the market with product, costing sales and causing losses from discarded batches, the root causes of the problem were unknown.
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Approach: |
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The client asked Tunnell to identify the root cause of the problem within a ten-week time frame and recommend actions to mitigate or eliminate the issue. Employing a cross-functional approach, Tunnell deployed a team that included a project manager, a formulation scientist, a process engineer, a statistician, and a data analyst . Batch record data was entered into a comprehensive database for over 140 selected batches representing good and bad process performance. Focus interviews were conducted with key personnel from relevant levels and functions. A detailed review of previous investigations and documents was completed, and detailed process observations were made. The statistical and scientific review pointed to a key processing step and a raw material as the most important sources of variation. Two outside experts were consulted and provided additional insight into the team’s observations and statistical correlations.
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Results: |
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Outcomes
of this effort included:
The factors that contributed to the dissolution problem were
systematically identified.
Short term actions were taken that moved the process average
from an unacceptable to an acceptable level and reduced process
variability.
Mid- and long-term recommendations were developed and prioritized
to further mitigate or eliminate the problem.
Data-driven analysis, along with iterative technical insight,
was employed to develop a model of the factors responsible for the
observed dissolution variability.
Confirmatory trials and optimization experimental designs were
recommended to
further optimize the client’s process.
Work was completed within the required time frame and budget.
The client’s capability to supply the market was improved.
Expected savings from a reduction in discarded batches is estimated
at $1-1.5M/yr.
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