How the FDA Data Integrity Draft Guidance is Affecting the Pharmaceutical Industry

Data integrity, as part of an automated production system, is an important factor for the success of a pharmaceutical.  Inconsistencies in data compliance can deny vital information from government agencies, payers, and patients. The pharmaceutical market has seen many drug makers letting compliant data collection and maintenance slip through the cracks in recent years, necessitating FDA warnings. As a result of recent cases of data collection negligence, the FDA has issued warnings to a number of pharmaceutical manufacturers.

As many as 21 warning letters were issued by the FDA in 2015 to pharmaceutical manufactures. In response to these violations, nearly one year ago, the agency released the FDA Data Integrity Draft Guidance. The data guidance provided a clarification on earlier regulations and suggestions for easier regulation compliance. So, now, one year after its release, is the FDA Data Integrity Draft Guidance making a difference in pharmaceutical production?

The new guidelines have clarified the FDA’s position on data reporting: all data must be correctly collected and analyzed for any product. By reporting the entirety of data collected, companies can produce more reliable products.

Earlier this year, a pharmaceutical company based in Japan was warned for the production and commercialization of drugs based off incomplete data, the company having used specific testing results. The warning letter to the Japanese manufacturer explained was explained as a result of failure to divulge multiple test results and a failure to maintain electronic records for data uniformity and tracking. One solution to this may be to implement Manufacturing Execution System (MES) data collection and maintenance programs. Utilizing an MES can easily track and record all production data, ensuring comprehensive test results. The new clarification of exposing all data means that the information not divulged by this company could hurt its chances of FDA approval, market access, and, ultimately, drug success. In another recent warning letter, to a China-based manufacturer, the FDA uncovered that the company was devoid of a quality unit. In this instance, the data coming from this company was not fit for US acknowledgement without specific, documented quality control procedures. To combat this issue, the FDA recommends separating quality and production responsibilities to ensure that each task is specifically assigned. This greatly reduces the risk of quality manipulation and streamlines FDA compliance.

Another solution to ensuring separation and compliance in production procedures is MES validation. Validating MES programs guarantees that specific duties are performed in a regulatory fashion. The FDA recommends that in addition to MES validation, pharmaceutical manufacturers provide distinct user controls under the program to assign and track task progress.

After the release of the data guidance in April, the FDA sent 50% more warning letters to pharmaceutical manufacturers throughout 2016 than in 2015. This could be attributed to a myriad of reasons, one being that the data guidance was only released in April, giving drug makers little time to completely reform MES and production procedures in the proceeding eight months. And during these months of change, companies were no doubt experimenting with their manufacturing to find the right avenue for their production needs. So far in 2017, FDA data warnings have been reduced to just over a quarter of 2015’s total letters and just 15% of 2016’s, signaling a change for drug makers. Recently, manufacturers have come forward who have not received FDA warning letters in the past year stating that the guidance has encouraged them to reevaluate their own quality standards to better optimize for FDA compliance, supporting the industry’s dedication to regulatory compliance.

In 2017, industry leaders are looking at data integrity to produce better quality products. Producing pharmaceuticals comes with many challenges, from navigating data integrity, to MES challenges, the industry is facing more manufacturing pressure than ever. To learn more about FDA Data Integrity navigation in 2017, register for the 2nd Annual Manufacturing Execution Systems Conference, May 22-23, in San Antonio, TX.