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PHARMACEUTICAL INDUSTRY :
Microbiology Lab Remediation
and Process Improvement |
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Client: |
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The vaccine manufacturing facility
of a major global pharmaceutical company. |
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Problem: |
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Significant pressure was being
placed on an aging microbiology laboratory because of a number
of factors: the upcoming launch of a major new product, the need
to qualify/validate new equipment and procedures, and the recent
loss of several of the more senior/experienced analysts and supervisors.
The situation was further compounded by an increase in laboratory
investigations and growing concerns about lab efficiency/productivity
in light of the current challenges. |
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Approach: |
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A Tunnell cross-functional team
of microbiologists and process/organizational improvement SMEs
worked in partnership with senior management and staff to quickly
assess the current state and capabilities of the facility. This
entailed: (1) identification of opportunities for near-term improvement,
(2) development of prioritized remediation plans, and (3) implementation
of the highest-return corrective actions that were needed. Included
in this was an analysis of:
- Test methods
- Analytical results and quality documentation
- Current and upcoming workload
- Suitability of current equipment/facilities
- Laboratory workflow
- Staffing, staff competencies, training,
and work assignments (supervisory and technical)
- Consolidation of efforts/activities
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Results: |
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Several critical issues were quickly
identified and addressed in partnership with the client regarding:
(1) modifications to workflow, (2) centralization/consolidation
of equipment and facilities, and (3) improved training for staff
(both supervisory and technical). These actions resulted in a marked
improvement in throughput (30% - 40%), significant decrease in
investigations, and visible increase in morale and self-confidence
within the laboratory. |
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