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Pharmaceutical Industry: Microbiology Lab Remediation & Process Improvement

Capability

Biotech Support
Regulatory, Compliance & Quality
Technical Services

Client

The vaccine manufacturing facility of a major global pharmaceutical company

Problem

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.

Approach

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

Results

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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