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Pharmaceutical Industry:
Compliance Performance
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Client: |
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An international
pharmaceutical company with a major presence in the U.S. and products
that include pharmaceuticals (e.g. solid dose, liquid, sterile) and
biopharmaceuticals (e.g. peptides, recombinant therapeutic proteins,
monoclonal antibodies).
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Problem: |
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Regulatory authorities
(FDA) inspected a U.S. facility and made multiple observations about
current practices as well as historical patterns. Significant actions
(i.e. injunction) were threatened, and a limited period of time was
granted for the company to demonstrate improvements in quality system
requirements.
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Approach: |
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An independent
evaluation of the company’s compliance history was performed by Tunnell
consultants. The results were quantified to identify the most critical
and frequent citations. A communication plan was developed to share
this information with senior management and departmental staff. Teams
were created to address the most critical areas requiring remediation.
Consulting support included subject matter experts, management consultants,
project managers, and a technical/functional support staff. Teams
of consultants and company employees were well integrated, focused,
had planned daily interactions, and regularly scheduled updates were
made to management.
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Results:
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A general FDA
inspection took place less than 6 months after project initiation.
The results of these efforts, as well as many of the project plans,
and the rationale and approach we took, were highlighted to the FDA
during inspection. The FDA immediately took the client out of an “export
hold” status.
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