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Pharmaceutical Industry:
Action and Alert Limit Development
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Client: |
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A major
global pharmaceutical company with facilities in the U.S. and Puerto Rico
developing and manufacturing ethical drugs in a variety of dosage forms
including parenteral, solid and liquid.
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Problem: |
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Results
from an FDA audit revealed that product and process specifications were
established and in use based on arbitrary, non-statistically based rationales.
The citation required that the company develop a statistically sound set
of action and alert limits based upon actual process capabilities for both
attribute (e.g. packaging line defects) and variable (e.g. fill volume)
types of process performance parameters.
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Approach: |
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Working
in partnership with a cross-functional client team made up of representatives
from QA, QC, Manufacturing, Technical Services and others, Tunnell designed
and implemented a process for baselining process performance, evaluating
process variation for stability and predictability, determining process
capability (e.g. s, Cpk), evaluating appropriateness of current manufacturing/packaging
parameter targets (e.g. fill volume), and making recommendations for changes
to current action and alert limits.This approach also included development
of the protocols for establishing these limits as well as the forms and
formats required. Because the data was not readily available, the Tunnell
team "mined" the necessary data from the batch records.
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Results:
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Over $1
million saved in first year from improved filling yields o Identified opportunities
for process variation reduction thereby reducing number of OOS results and
manufacturing deviation reports generated. Developed an FDA defensible approach
for establishing action and alert limits for new products on a go-forward
basis, thereby avoiding future FDA citations in this area. Formulated recommendations
for ongoing real time trending of critical process data thereby enabling
the client to monitor process performance and react in a timely fashion
to process shifts and trends.
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