 |
PHARMACEUTICAL INDUSTRY :
Inspection Readiness |
|
| |
Client: |
|
A major generic pharmaceutical company |
| |
|
|
|
| |
Problem: |
|
The client was under intense regulatory scrutiny and had received a number of 483s over a two-year span. They were preparing for a follow-up inspection by the FDA and wanted to ensure that the manufacturing organization was ready. Their previous inspection readiness activities involved conducting audits of the manufacturing environment. Senior management wanted a new approach that would be more effective at encouraging and reinforcing desired shop floor behavior. |
| |
|
|
|
| |
Approach: |
|
Tunnell and the client developed a focused Day In the Life Of (DILO) methodology using Subject Matter Experts in Manufacturing to work one-on-one with operators and front line supervisors. Their focus was to mentor and coach the manufacturing staff using Socratic interactions and constructive feedback about activities. Working from a standardized methodology, these mentors also identified areas of potential non-compliance events and recommended steps to reduce the possibility of their occurrence. |
| |
|
|
|
| |
Results: |
|
• |
The FDA inspection resulted in no critical or major GMP observations on the manufacturing floor. |
• |
The coaching and mentoring approach avoided the adversarial nature of the evaluation and increased engagement by the manufacturing staff. Issues that may have been hidden or not readily visible were brought to light and addressed. |
• |
The cooperative environment produced immediate modifications to operator and supervisor behaviors and allowed the staff to suggest solutions and take ownership of corrective actions. |
• |
A detailed analysis of manufacturing unit operations and quality systems identified areas of improvement that the client used to evaluate longer-term improvement initiatives and to track remediation activities. |
• |
The methodology was adopted by the client to conduct inspection readiness and continuous improvement activities within other departments. |
Click here to view charts
|
| |
|
|
|
| |
 |
|
|
| |
|
|
|