Life Science Quality Management Can Help Companies Avoid Adverse Regulatory Action

life science quality management
Proper life science quality management is necessary to avoid regulatory action.
Image source: Flickr CC user Brandon Giesbrecht

Attention to detail is par for the course within most modern industries and fields, including scientific research. In addition to finding ways to remain competitive in today’s crowded market and maintaining margins in the face of rising R&D costs, life science organizations now have to take into consideration more regulatory oversight from federal agencies. The FDA recently proposed new requirements for quality metrics reporting. On an even more stringent note, regulatory agencies are increasingly holding sponsor companies responsible for quality standards followed at contract organizations. No matter the area, the message is clear: life science quality management is the top priority and is everyone’s responsibility.

Consider the Drug Quality and Security Act. Passed as the result of lapses at a facility that ultimately had fatal consequences, the legislation expanded the FDA’s oversight of the pharmaceutical compounding industry. The incident perfectly illustrated the negative repercussions of poor life science quality management. Because of the resulting deaths, the facility’s reputation was irrevocably damaged. Many firms can find it difficult to repair a tarnished image caused by loss of public faith.

Life Science Quality Management Is a Continuous Process

Given the magnitude of the circumstances leading the passage of the Drug Quality and Security Act, it would be expected that other compounding facilities would be more vigilant. Unfortunately, it appears that some trends can be difficult to reverse. Over the past decade, there has been an observable increase in the number of Form 483s issued by the FDA, with 97 in 2005 to 121 in 2014. Given this data, the fact that another inspection at an organization revealed multiple violation sadly doesn’t come as too much of a surprise.1 While no adverse health effects were associated with the facility, the findings—which included microbial contamination and lack of environmental monitoring—conjure up negative associations that can easily undermine public confidence.

Even though increased regulatory oversight puts additional pressure on organizations, proper life science quality management supports the development and manufacture of quality products in spite of intense scrutiny. The reality is that high standards and adherence to protocols can minimize compliance risks. One way to accomplish this goal is by adopting an automated quality management system with continuous feedback. Such a system can support continuous improvement by flagging any deviations from acceptable limits, which in turn would alert the relevant departments that corrective action is required. Organizations can take action earlier in the release cycle rather than at the end.

Digital Solutions Can Ease the Burden of Life Science Quality Management

Maintaining high life science quality management can be a serious investment for many organizations. Quality procedures already make up a signification portion of overhead and can require more resources than firms may anticipate. That may explain why federal agencies are still finding companies deficient on multiple fronts such as a lack of documented procedures to guarantee drug quality2 or a failure to follow up on out-of-specification results.3 Even so, inefficient organizational procedures are no excuse and regulatory agencies have demonstrated that companies will be held accountable, even if the offending facility is in another country or a collaborating firm.

In order to remain compliant while still maintaining high quality, organizations would greatly benefit from finding ways to streamline their quality management processes. This doesn’t simply mean adopting an automated system to assess quality in each department. While implementing digital tools seems like a reasonable solution to tackle the problem, disjointed adoption can actually lead to more inefficiency and problems. Rather than disparate processes that can overlap or even be redundant, companies can look for an integrated solution that supports their aims to maintain high quality and meet regulatory compliance in a harmonized manner from start to finish. From ensuring that materials used on-site are of high quality to strict adherence to quality protocols, the right set of processes can enable their efforts to release quality products and avoid adverse regulatory action.

BIOVIA specializes in digital solutions that support life sciences organizations in their efforts to maintain quality and remain compliant with regulatory guidelines. BIOVIA CISPro is a flexible chemical management system that enables users to track and source the materials used on-site in their development and manufacturing processes. By providing organizations the ability to store information about ingredients, they will be more able to identify potential causes when something is out of specification. In conjunction with BIOVIA Total Quality, a comprehensive life science quality management solution that ensures quality and compliance throughout the entire product life cycle by integration, automation and harmonization, companies can streamline all relevant processes in their organization. If you’re interested in learning how these digital solutions can benefit your firm’s efforts to maintain quality in the face of rising regulatory oversight, please contact us today to learn more.

  1. “FDA says microbial contamination found at Montana Compounding,” January 21, 2016, http://www.fiercepharma.com/regulatory/fda-says-microbial-contamination-found-at-montana-compounding
  2. “FDA lambasts Sri Krishna Pharma plant in new warning letter,” April 20, 2016, http://www.fiercepharma.com/manufacturing/fda-lambasts-sri-krishna-pharma-plant-new-warning-letter
  3. “Warning letters reveal some of the FDA’s biggest problems with Indian drugmakers,” January 13, 2016, http://www.biopharmadive.com/news/warning-letters-reveal-some-of-the-fdas-biggest-problems-with-indian-drugm/412076/