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PHARMACEUTICAL INDUSTRY :
Process Capability and Control |
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Client: |
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A
major global pharmaceutical company with facilities in the U.S. and
Puerto Rico manufacturing ethical drugs in a variety of dosage forms.
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Problem: |
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A
product with a long manufacturing history was exhibiting an unacceptable
degree of variation in a critical release parameter resulting in some
batch rejections and many investigations. In total, the client was
collecting data for over 50 parameters. Early development reports
and "tribal knowledge" suggested the client knew which of the 50 parameters
were "critical" to controlling variation in the key release parameter
in question. The data for those parameters resided in multiple locations
(e.g. analytical lab, batch records, raw material CoAs, etc.) and
in both electronic and paper form. Recent client efforts made to reduce
this variation met with only modest success, suggesting the relationship
of key product parameters was not fully understood. |
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Approach: |
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A
Tunnell team, consisting of a pharmaceutical scientist, a statistician,
a process analyst, and a data analyst, followed a structured methodology
for identifying the root causes of process parameter variation customized
for the client's specific situation. Historical process data for all
variables was collected and organized into a single electronic database.
Process control charts were developed and analyzed. Process capability
analysis was performed. Variables were grouped and prioritized based
on the capability analysis and insights from Tunnell scientists. In-depth
process walk-throughs by experienced pharmaceutical scientists were
conducted. Advanced statistical analysis was performed on the data.
Focus interviews and focus groups were conducted to mine the collective
insight of the client organization.
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Results: |
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Multiple sources of variation were identified
New process knowledge was gained related to the relationship between
key process parameters (cause-and-effect relationships)
Specific recommendations were developed and implemented to reduce
variation resulting in significant improvement in process capability
and reduced risk of batch rejection and investigations |
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