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PHARMACEUTICAL INDUSTRY :
Process Validation |
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Client: |
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A
top "10" global pharmaceutical firm, predominately OTC pharmaceuticals,
with major market position and strong pipeline in a variety of therapeutic
areas. |
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Problem: |
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The
client desired an independent evaluation of the process validation
status of several suspension and tablet formulations. A decision for
a matrix approach to validation was in review but no decision had
been effected. The critical process parameters for validation had
not been completely determined and the specifications associated with
the critical process parameters were not established. A valid statistical
approach to validation was requested. |
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Approach: |
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Tunnell
worked in conjunction with the client's Process Development, Analytical,
QA/QC, Manufacturing, and Product Development personnel to create,
resource, and successfully execute a comprehensive validation project.
Assessment of the process, critical process parameters, specifications,
matrix approach and statistical design were implemented. |
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Results: |
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A comprehensive validation plan was created, with both high-level actions and detailed, checklist driven tasks established within an agreed up on timeframe
The process was assessed and gaps were observed. Gap closure was recommended and effected
A statistical and matrix validation program was presented, accepted and executed
A master validation plan was created, leading ultimately to solidly-backed and documented validation dossiers
The validation batches were monitored, sampled, analyzed and reported by Tunnell resources
All documentation was written by Tunnell (master batch record, validation protocol, statistical analysis and validation report)
Documentation was updated, including master SOPs
Process capability analysis was performed
A future validation plan was established |
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