A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences

When quality and compliance are incorporated into 
operational  to thrive in the competitive life sciences marketplace. 

Increasingly strict regulatory measures are drawing attention to the inadequacy of the systems and processes life sciences companies use to manage quality and production. A new eBook from LNS Research entitled A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences outlines some of the major challenges faced by life sciences companies and shows how prominent organizations are successfully handling those difficulties. 

The eBook highlights a variety of timely topics, including:

  • the pressures placed on life sciences companies by the cGMP regulations set forth by regulatory bodies like the FDA 
  • the benefits of “holistic” quality management 
  • some examples of leading organizations’ approaches to quality challenges 
  • data demonstrating the effectiveness of electronic quality management 
  • systems recommendations for improving quality going forward

The basis of the eBook comes from a 2012-2013 LNS Research Quality Management Survey completed by over 500 executives and senior staff from a variety of different-sized life science companies across a wide geographic and industry range. More than half of those surveyed represented discrete manufacturing industries, with the largest portion (43 percent) of them coming from medium-sized companies.
Life Science Megatrends
Survey responders pointed to a variety of trends that have contributed to the current state of the life science industry. Among the trends identified, five were consistently reported as being the most significant:
  • longer life spans of the populations served
  • the inevitability of affordable, individualized treatments tailored to a patient’s needs based on genotype
  • regulatory burdens, specifically the increase in quality system inspections (to which, it should be noted, leading companies are responding to by improving collaboration efforts with research and manufacturing partners in order to reduce risks and decrease pressures)
  • rising customer demands and expectations
  • the continued global expansion of manufacturing
Individual Company Responses
With the aforementioned trends significantly affecting life sciences markets, one can’t help but wonder how the industry stalwarts are responding. The LNS Research survey pinpoints several examples of global leaders’ responses. For instance:
  • Pfizer, like other market leaders, is making clear statements about manufacturing and quality management in its annual reports.
  • Consolidation continues to be on the rise. As mergers continue to proliferate, enormous efforts are being to harmonize global manufacturing and quality best practices.
  • Indicative of recent regulatory actions, the two most pervasive lapses in quality subsystems involve CAPA and product and process control (P&PC). As the FDA continues to increase its focus on quality, market leaders are attempting to rise to the challenge by bolstering quality.
Industry Trends and Challenges
When asked about their quality management challenges, survey respondents noted particular issues with the lack of “quality culture,” the ability to effectively measure quality metrics, and the problems posed by disparate systems and data sources. Other concerns of note included the lack of visibility into supplier quality, an absence of a formal process for continuous improvement, and the deficiency of executive support. Pharmaceutical companies in particular appear to face considerable challenges with visibility into supplier quality.

On the operations side, survey participants reported timely visibility into manufacturing performance metrics, lack of cross-departmental collaboration, and disparate systems and data sources as being their most significant difficulties. When questioned about the top industry trends affecting their organizations, nearly two-thirds of life sciences executives pointed to regulatory requirements for quality management as having the greatest impact. Other increasingly important trends include regulatory requirements for serialization and traceability and the growing need to reduce costs due to new market conditions.

It should go without saying that accelerating the time it takes for a product to get from R&D to patients in need is always a life science company’s primary concern. Along these lines, the biggest roadblocks to New Product Introduction (NPI) identified by the executives who responded to the LNS Research survey were issues relating to quality management. This hardly comes as a surprise since the companies that have the most seamless NPI processes are also the apparent market leaders. Other major barriers to getting new products on the market include supply chain optimization, validation and gaps in product portfolio management.

Creating a Culture of Operational Excellence
Most life sciences companies lack a “culture” of quality that pervades every aspect of the enterprise. All too often, quality is considered to be the responsibility of the quality department and nothing more. In fact, half of the executives polled by LNS Research stated that they believe quality is a department, not a responsibility. It is the opinion of LNS Research that such a mindset inevitably results in quality events being dealt with reactively and that it will cause an organization’s “quality police” to be viewed as a burden rather than a benefit.

The information gathered by LNS Research suggests that life sciences companies will achieve greater success by approaching quality proactively and incorporating quality and compliance into an overall operational excellence strategy. When employees share a common vision of operational excellence, they can cooperatively form an all-encompassing business operating system that unites global quality, supplier quality, and other management system disciplines. LNS Research proffers several practical suggestions to help executives initiate a culture of quality within their organizations, such as:
  • Development of short- and long-term plans for internal education, process improvements, and capital investments
  • Third-party audits
  • Rewards-based performance programs for quality improvements
  • Requirement that quality management metrics be used in all operations

Software for the Next Generation
Of the hundreds of companies surveyed by LNS Research, 78 percent reported that they are operating in a state of quality management disconnect, largely due to deficiencies that could be remedied by technology. Paper-based quality management systems and traditional manufacturing operations management (MOM) software solutions have hamstrung many life science companies. On the other hand, companies that have implemented a comprehensive MOM software suite report a 10 percent higher median overall equipment effectiveness (OEE) performance that their less efficient counterparts and enjoy nearly twice the improvement in on-time complete shipments (30 percent vs. 17 percent for companies that don’t use MOM software). The contrast between companies that have implemented enterprise quality management software (EQMS) is even starker: companies with EQMS systems had a median successful NPI rate of 86 percent, while those without EQMS experienced a median rate of just 56 percent. The research gathered in the survey supports the model that an integrated platform approach to quality enables life sciences companies to maintain flexible operations while keeping pace with market demands.

James Jardine is a marketing communications specialist for MasterControl Inc. He has a bachelor’s degree in journalism from the University of Utah and is based in MasterControl’s headquarters in Salt Lake City, Utah.