By Carmen Medina, MPH, Ph.D., PAREXEL VP Technical
Four of our most crucial FDA-regulated industries continue to receive repeat observations in areas that invariably contribute to dangerous drug shortages, recalls, and quality defects. In 2017, the FDA issued 115 observations to the biologics industry, a 37% increase over the 84 issued in 2016. In response to this increasing trend, PAREXEL has developed a unique platform and approach for collecting, analyzing, and proactively using quality and production metrics to help predict and mitigate the risks this trend presents to both blockbuster biologic products and the burgeoning biosimilars industry. Generating meaningful and actionable data, related to quality systems’ outputs, such as rate of CAPA effectiveness and failures or rate of OOS results, coupled with operating data, such as ratio of lots made versus rejected and out-of-trend results for a piece of equipment or utility can significantly improve everyone’s ability to detect and meaningfully respond to potential crisis in a timely manner. Data fails to be meaningful if it is not actionable in real-time. The quality and compliance deficiencies most frequently cited include: lack of adequate process controls, inadequate management of deviations, OOS results and CAPA, and data integrity lapses.
In the area of Bioresearch Monitoring, the agency issued 243 observations in 2017, indicating a 13% increase over the previous year. While PAREXEL has been designing clinical trials for over 35 years, it now offers a tried and trusted approach to evaluating the veracity and viability of data collected during Phase 2 and 3 trials, which includes an assessment of data integrity. This newly developed program aims to prevent the increase of data integrity observations across all industries.
While the device industry received 934 observations in 2016, revealing only a 10% increase during 2017 (1030 observations), PAREXEL’s extensive involvement with the medical device industry reveals that the increase relates primarily to inadequate management of CAPAs and lack of complete design controls, prior to the pre-approval inspection. Some of the citations assigned to this industry also related to lack of Part 4 compliance. PAREXEL’s Part 4 training program and extensive experience with the design and commercialization of all classes of devices has proven effective in averting these repeat observations for its clients. Interestingly, FDA observations throughout the drug industry did not reveal a discernable increase from 2016 to 2017; specifically, 691 to 694 observations, respectively. Nevertheless, the observation trends noted are similar to those of the above FDA-regulated industries; namely, inadequate process controls, management of deviations and OOS results, coupled with data integrity concerns.
These observation trends, regardless of their industry, are preventable with the use of a simple tool—Quality Metrics. Within our global learning community network, PAREXEL has provided ample evidence demonstrating how enterprise-wide analytics provides a 360° feedback-loop of typically disjointed data; while also fostering predictability, rapid detection, and accountability. When used as an advanced warning system, quality metrics supports targeted risk mitigation; furthermore, it is an essential tool designed to reduce and prevent these all too familiar observation trends.