How Will Proposed FDA Quality Metrics Push Life Sciences Firms to Meet Standards?

Total Quality

FDA quality metrics
What do the proposed FDA quality metrics changes mean for life sciences organizations?
Image source: Flickr CC user John Fischer

Quality management remains a top concern of many life sciences companies. How do they streamline quality processes to minimize bottlenecks and speed up the release cycle to gain advantage in today’s competitive pharmaceutical market? Even more importantly, how do they achieve these goals while keeping costs down in order to preserve and increase margins? As we’re seeing with increasing frequency, organizations will need to concentrate on the latter due to the rise of low-cost alternatives.

In addition to these concerns, another issue has come into play with recently released draft guidance on new FDA quality metrics reporting requirements. Quality metrics themselves are nothing new. The pharmaceutical industry already uses them to monitor quality control processes and drive continuous improvement. The FDA, however, believes it can use this information to help compliance, develop inspection policies and improve their ability to predict future drug shortages.1 While the intentions behind these proposed changes certainly come from a good place, they also pose challenges to life sciences firms that manufacture FDA-regulated products.

Concerns Raised by the Proposed FDA Quality Metrics Guidelines

The new FDA quality metrics guidelines are largely driven by the desire to provide a consistent supply of necessary medications by reducing potential disruptions:2

  1. The FDA quality metrics will help evaluate manufacturing facilities and processes.
  2. The information obtained will aid the identification of facilities that are most at risk of quality problems.
  3. This knowledge will allow the agency to deploy resources effectively and efficiently to address these observed issues.
  4. By encouraging companies to maintain robust quality management systems, drug shortages caused by interruptions during the manufacturing process can be minimized and prevented.

As mentioned earlier, the logic behind the proposed FDA quality metrics reporting is sound. The problem, however, lies in implementation. Quality management systems already use a significant amount of resources within life sciences organizations. The burden posed by the FDA guidance will require even more. Collecting the information the agency desires will most certainly increase costs. For example, one of the proposals outlined in the guidance requires that companies obtain quality data from their supply chain. But a pharmaceutical firm can make use of a multitude of suppliers to provide the ingredients necessary to manufacture its products. Gathering that amount of information can easily far exceed existing capabilities, which means companies would need to invest in even more resources to meet the proposed standards. This doesn’t even take into account potential inefficiencies and bottlenecks that could be introduced in the process of gathering and compiling the reports the FDA wants.

A Total Quality Strategy Can Support Companies’ Efforts to Meet FDA Quality Metrics Reporting Standards

If life sciences organizations aren’t already aware of the advantages offered by a harmonized total quality strategy, the FDA draft guidance should certainly encourage them to consider and adopt such a plan. Even though it is likely the agency will heed advice given during the commenting period and revise the proposal, it is also likely that some form of FDA quality metrics reporting will be instituted. To that end, firms should examine existing quality management systems and determine ways to improve implementation now.

The main advantage of a total quality strategy is that all quality management processes are linked, from discovery to development to manufacturing. With such a unified system in place, no department exists in true isolation, which means that quality is both refined at every step and tracked efficiently. Under these conditions, gathering quality data from the supply chain would be a far less daunting task.

Another benefit would be cost minimization. An effective total quality strategy makes use of automation and closed-loop feedback. By automating non-value added items, quality management systems are streamlined, freeing up productive time for other tasks. The amount of time and manpower required to accomplish specific tasks are effectively reduced, providing the additional advantage of increased efficiency and release cycle speed.

If the FDA heeds advice offered by the pharmaceutical industry, the agency will hopefully revise their draft guidance to include a phased implementation. The amount of resources required to collect the desired information may not change, but a phased implementation would at least give companies more time to adjust to the new guidance. Since a total quality strategy supports the collection of data in each stage, organizations will be able to quickly adjust to shifting FDA quality metrics reporting standards, thus reducing the growing pains typically associated with these kinds of regulatory changes.

As much as we’d wish otherwise, increased regulatory oversight appears to be current trend for life sciences companies involved in drug development and manufacturing. We’re seeing this shift not only in proposals such as the FDA quality metrics reporting standards, but even in inspections. From 2010-2012, the FDA issued 5 warnings to companies, but that number shot up to 24 in 2013-2015.3 Under the new draft guidance, we may even see more. To avoid receiving these citations, life sciences firms will need to emphasize their quality processes and elevate them to the highest standards possible.

BIOVIA Total Quality is a comprehensive solution that supports a total quality strategy for life sciences firms. It offers capabilities that address the needs of quality process management, quality control and testing, materials quality, quality document management and quality and process data analytics via a comprehensive approach. Its implementation reduces the costs of poor compliance and poor quality as well as encourages high-quality standards throughout every stage of the product life cycle. If your organization is interested in adopting a total quality strategy to meet the new standards outlined in the FDA quality metrics guidance, as well as other regulatory guidelines, then please contact us today to learn more.

  1. “Drug Industry Has Concerns With Quality Metrics Guidance,” December 4, 2015,
  2. “‘Quality Metrics’: FDA’s plan for a key set of measurements to help ensure manufacturers are producing quality medications,’ July 28, 2015,
  3. “FDA quality focus will definitely mean winners and losers, report says,” February 8, 2016,

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