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Pharmaceutical Industry: Laboratory Efficiency / Training

Capability

Operational Improvement
Regulatory, Compliance & Quality

Client

A rapidly expanding global generic pharmaceutical firm with U.S. operations

Problem

Rapid growth and the expansion of the firm’s targeted generic introductions placed a significant strain on the R&D laboratory operation leading to increased errors and lower overall productivity. Faced with tight timelines, an increased project workload, and concern about resultant delays in filing ANDAs, the senior management of this facility asked Tunnell Consulting to assess the current status, staffing, and capabilities of the laboratory and to recommend how best to optimize throughput and efficiency while reducing errors.

Approach

Selected interviews were conducted with a cross-section of the R&D laboratory staff in combination with process assessments and documentation reviews to support a rapid but thorough evaluation of the laboratory operation that focused on:

• Quality of the current lab training program and practices
• Overall competency of analysts (relative strengths/weaknesses)
• Changing roles/responsibilities of the supervisory, senior scientific, and analytical staff
• Identification of ‘bottlenecks’ and opportunities for simplification in lab processes/procedures
• Modes and effectiveness of communications
• Selection and use of metrics

An implementation plan was subsequently developed that recommended several key opportunities for improvement, including:

• Expanding and standardizing the lab training program (basic and advanced technical skills, cGMP/documentation training, training and qualification of lab trainers, etc.)
• Developing a formalized mentoring/continuing learning and technical support program for analysts
• Introduction of metrics

Results

Working in partnership with the R&D staff, Tunnell developed a more thorough/robust R&D lab training program that resulted in a significant increase in competency, self-confidence and increased compliance, and a reduction in errors. This, coupled with the introduction of more effective metrics and better defined roles and responsibilities, resulted in more than a 30% increase in throughput/productivity. Bottom-line savings to the company was projected to be $2.1 million/year.

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