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PHARMACEUTICAL INDUSTRY :
Process Validation |
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Client: |
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A
top "10" global diagnostic and pharmaceutical firm, instantly recognizable,
that includes prescription and diagnostic pharmaceuticals. |
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Problem: |
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The
client was under sanctions imposed by the FDA, with a commitment to
evaluate the process and analytical validation of diagnostic products
and devices. Tunnell and the client agreed that the evaluation would
include assessment of whether: 1) correct critical process and analytical
parameters had been identified and addressed, 2) critical specifications
were correct and justified, 3) the validations were executed and documented
correctly and, 4) the validations met and would continue to meet regulatory
and industry validation standards. Tunnell and the client agreed that
identified deficiencies in the assessments and commitments for future
validation activities would be addressed via co-authored protocols.
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Approach: |
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Tunnell
worked in conjunction with client personnel to create, resource, and
successfully execute a comprehensive assessment and gap analysis project.
The assessment was designed to: 1) provide a comprehensive history
file (from existing documentation) to support the product and specifications,
2) provide constructive changes to existing validation reports and
include written protocols (if necessary) to correct or strengthen
compliance to a validation program, 3) provide written protocols to
ensure continued compliance, and 4) provide the methodology to determine,
monitor and understand key product attributes in the future. |
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Results: |
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Provided the client with a comprehensive validation assessment,
with both high-level actions and detailed, checklist driven tasks
that were required to correct deficiencies and/ or obtain a satisfactory
compliance level.
Provided the client with a written protocol to ensure the validation
initiative would be carried forward (3-year plan) and would provide
confidence that the process / methodology continued to meet product
specifications and qualities.
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