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Pharmaceutical Manufacturing - Research & Consulting

As stated by one of our research partners, "Good quality is life enhancing. Bad quality is life threatening." It's also company threatening. Due to increased FDA scrutiny, manufacturing quality is increasingly a key driver in successful and timely product launches, optimizing revenue streams, enhancing the company's reputation, and maximizing shareholder value. With half-billion dollar fines, consent decrees, 483 warning letters, and repeat inspections setting the tone, several pharmaceutical clients have come to us looking for ways to optimize the quality function at their manufacturing facilities.


Our research dissects the quality function into major components, looking at details such as
  • department structure
  • roles and responsibilities
  • relationships between corporate and the sites
  • staffing levels
  • education backgrounds
  • experience levels. 
Our quality research has also focused on subjects such as
  • manufacturing sciences and emerging technologies
  • technical services (validation and procedure writing and changes)
  • laboratory staffing and efficiency issues
  • part 11 compliance
  • deviation/event management
  • performance measurement
  • best practice sharing between facilities.

We have built a strong capability and access to leading experts at top companies. Best Practices LLC is considered a valuable resource in measuring and enhancing the quality function. With our insights in hand, you are well positioned to enhance product quality, reduce variability, hire and retain the best quality personnel, and optimize your quality investment. In addition, we are positioned to relate the very latest trends and practices in the quality organization performance, enabling you to stay one step ahead of the auditors, and to maximize the quality of life of patients.

Our team employs best practice research through surveys and interviews, benchmarking, assessments (comparing quality organizations with those we've documented from world-class companies), and traditional consulting to advise our clients in achieving dramatic impact across their entire quality function. 


Best Practice Methodology

Using our proprietary Best Practice Blueprints for Excellence methodology, Best Practices' analysts first help our clients assess their specific needs and what will make a study not only successful, but a key tool in future developments within the company. Together with the client, we work to identify the prospective benchmark class of partners, then identify the areas to probe and questions to ask during our research. Such research tools include 

  • detailed, metric-oriented surveys
  • in-depth phone interviews of executives running these operations
  • site visits of world-class operations
  • assessments comparing client operations with those studied at other companies
  • extensive background research, including proprietary and public database searches and web research on the topic
Following refinement of the research tools, the client organization gives its own input to serve as a baseline in interactions with other companies. These benchmark partners are screened for objective and subjective best-in-class performance, with top organizations being invited to participate and receive a streamlined version of the findings of our research. Considerable value is added by comparing, analyzing, and synthesizing our findings; which serves to make detailed recommendations to our client based on the winning practices at other top companies. Since no single company has a lock on all the best practices, our client and research partners all learn from each other and gain valuable insights in eclipsing their competition.

Improving the Quality Function: Driving Organizational Impact & Efficiency

Most organizations face the challenge of successfully configuring their Quality organizations to deliver optimal performance, impact and efficiency in today's market. Increasing regulations and pressure for organizational cost reduction further compound this issue. Companies across various industries can use information uncovered in this study to benchmark and improve their performance in critical quality areas such as:
  • Organizational Size and Management Structure- assesses size, structure, scope of service and roles & responsibilities of the Quality organization. Metrics covered include: organizational effectiveness ratings, corporate and non-corporate quality budgets, staffing levels (aggregate as well as segmented by manufacturing sites and total products).
  • Risk Measurement and Management- addresses topics such as Quality audits and self-assessments as well as critical-to-quality factors unearthed through analyzing voice of the customer. This section includes executive insights on effectively developing and managing a formalized risk management process. Metrics include: combinations of regulatory/certification audits with quality audits, frequency of site and vendor audits and product recall/failure rates.
  • Organizational Impact, Value and Performance- assesses financial impact of the Quality organization as well as performance management, measurement and value communication. Metrics include: percent of companies utilizing various quality tools and methods, quality cost savings and value communication tactic effectiveness ratings
  • Lessons Learned- highlights the key challenges and insights uncovered by executives at benchmarked quality organizations.

The Quality Function: Structure, Staffing, and Execution

One client was facing extraordinary attention from regulators, inspectors, stock analysts, and shareholders due to perceived and real shortcomings in the company's manufacturing quality. Our customer was looking for a mechanism to research and understand how the quality function was organized and staffed at top pharma companies. Issues such as structure, staffing levels at corporate and site, span of control, career path planning and retention, education levels and depth of experience in its quality people were of interest. 

For this engagement, our research team conducted detailed surveys of top pharma companies to understand the exact staffing levels, distribution, education backgrounds and tenure in the quality role. Study participants also were interviewed to understand the organizational structure, assignment of responsibilities, lessons learned, and top influencers in maintaining a world-class quality system. Our research presented not only how our client stood with respect to others on the performance metrics, but also identified scores of detailed best practices in quality management.

This study was conducted on behalf of a global pharmaceutical company. Six highly regarded companies participated as benchmark partners. With our insights in hand, our client was well positioned to optimize its quality structure and organization, focus efforts on career development and retention of quality personnel, and fine-tune hiring and training efforts. In turn, our research has a direct bearing on product quality, expense management, and reputation enhancement.c

Manufacturing Sciences and Technical Services

A key element in delivering consistent product quality relies on writing validation and operating procedures, and keeping these procedures updated in the context of advancing technologies and reducing production variability. Our research delves deeply into this topic, often called "technical services." One client recently created a vice president position to oversee this critical aspect in manufacturing quality. To prepare for the position, to further their industry knowledge on the subject, and to plan for potential staffing needs and organizational changes, our client engaged us to research the topic. 

Specifically, this study looked at technical services structure, staffing, roles and responsibilities, information exchange among sites, career path development, training, data handling, future technologies and the evaluation/adoption process, challenges and lessons learned. Our research involved surveying and interviewing executives from six top pharma companies. In addition, senior inspectors from the U.S. Food and Drug Administration were interviewed for their insights on the subject. Site visits to two leading participants were also conducted to observe, first hand and in great detail, the winning practices of these top companies. With our insights in hand, our client was able to identify a specific action plan to maximize the success of their department and to prepare it for a very challenging road ahead.

Quality Laboratory Management

Depending on the company studied, the laboratory function in the quality organization accounts for between 1/3 and 2/3 of all quality staffing. As a major source of investment, not to mention a critical aspect in ensuring product quality, the laboratory function is a area for analysis and optimization. The Best Practices LLC research team profiled a highly-regarded group of six companies, along with a set of contract manufacturers, to understand their performance in the lab.

As with other such projects, our client in this case was keenly interested in structural issues, staffing levels, spans of control, career path planning, and retention. Our research also delved into issues such as sample management, emerging lab technologies, part 11 compliance, scheduling, yields and rework, documentation and data management.

Other hot topics

Other hot topics on the radar screen of our research team includes part 11 validation, quality cost optimization/containment, deviation and event management, quality culture, variability reduction, internal auditing, and emerging technologies (automation, electronic signatures and record keeping, etc.) affecting manufacturing quality, data handling, and staffing.




 

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Cameron Tew,
  Executive Director, Research and Business Operations

(919) 767- 9246

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