 |
PHARMACEUTICAL INDUSTRY :
Compliance Performance |
|
| |
Client: |
|
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). |
| |
|
|
|
| |
Problem: |
|
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. |
| |
|
|
|
| |
Approach: |
|
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. |
| |
|
|
|
| |
Results: |
|
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. |
| |
|
|
|
| |
 |
|
|
| |
|
|
|