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Pharmaceutical Industry: Inspection Readiness

Capability

Regulatory, Compliance & Quality

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.

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