How has PDA’s Elements of a Code of Conduct for Data Integrity in the Pharmaceutical Industry impacted the companies of those who downloaded it?

The Code is a collection of recommended best practices for employee and management conduct related to data integrity, presented in a ready-to-use format. It was published on the PDA website in March 2016, available free for download. PDA’s Data Integrity Task Force, under the leadership of Anil Sawant, PhD, Vice President, Quality Management Systems and External Affairs, MSD, and Ronald Tetzlaff, Corporate Vice President, PAREXEL, developed the Code with the goal of sharing it with the industry at large. It was written to apply to employees, corporate officers, third-party suppliers and others acting on behalf of, or at the behest of, a company. This includes individuals that develop, test, manufacture or submit marketing authorizations for pharmaceutical and biological products. The Code was designed so that it could be tailored for each individual company’s needs. A company could implement the elements within the Code in their entirety or only certain elements identified as pertinent for establishing their own customized policies, standards, procedures, or other quality system elements to define data integrity requirements.

The task force aimed to distribute the Code of Conduct as broadly as possible, thinking it would be especially useful for smaller manufacturing firms, or those that supply raw materials, components or testing services who may not yet have taken this step toward quality system and culture maturity. It was developed to be used directly by smaller firms to shore up existing quality systems. Additionally, larger firms or contract givers could use elements of the Code to assess their current internal codes or use it to when drafting or revising supply and quality agreements. As of October 2017, more than 3800 copies of the Code have been downloaded. Most of the copies were downloaded in North America, Western Europe and Japan, which is consistent with PDA’s large membership in these regions. Analysis of website data shows the downloads have also occurred in regions representing areas of emerging pharmaceutical manufacturing as Africa, Eastern Europe, India and China (Figure 1). This is encouraging as it supports one of the task force’s goals of expanding education and tools to identify and rectify data integrity gaps.

Figure 1 Number of Downloads by Region Outside of United States, Western Europe and Japan

One year after publication, PDA sent a follow-up survey to those who had downloaded the document to learn about the outcomes of implementing the Code, collecting a total of 95 anonymous responses. Approximately 40% self-identified as a quality leader or member of quality staff and 20% as compliance leaders or compliance staff. Another 30% identified themselves as consultants. The remainder self-identified as members of manufacturing production, legal counsel, validation, development and marketing.

There was an almost even distribution in the size of the respondents’ companies as shown in Figure 2.

Figure 2 What is the Number of Employees in Your Company/Average in your Client’s Company?

Responses to the question regarding the location of manufacturing sites indicated survey respondents represent manufacturing sites from all regions of the world (Figure 3).

Figure 3 Where Does Your Company (or Client) Manufacture Products?

The survey also asked how the Code was used after being downloaded. More than half indicated they used the Code as a guide on good data integrity practices, while 33% used it as a benchmark to evaluate internal practices and 14% used the Code in developing agreements with outsourcing partners or suppliers. Almost 20% of the respondents adopted the Code in whole or in part into their internal business processes and practice. More than 90% of the survey respondents rated the Code as useful. A quarter also found it practical for their company or clients to adopt or follow.

More than 90% of respondents also indicated they believe it will help reinforce a culture of quality and trust within the pharmaceutical industry. This aligns with the original goal of the task force to raise awareness and provide useful tools within the pharmaceutical industry.

The survey included a question for openended responses. Here are some of the positive comments received about the Code:

• “I believe that your take on data integrity was accurate, because it is basically awareness of existing regulations. What I fear (and what you have thankfully not done) is over-engineering what regulatory agencies have already expected…similar to what happened with the term ‘risk-based.’ I applaud your paper because it was fundamental and basically summarized what was already expected in regs and guidances. I also liked that in reality it didn’t require a CSV group to create more templates (which I have already seen organizations do!) but instead incorporate these concepts into existing gxp processes (e.g., SOPs, CSV UR templates).”
• “CoC helps a lot about thinking policy in good GMP documentation practices. Thanx for that. This kind of guidance should be mandatory for equipment vendors as well.”

Some respondents expressed concerns about the structure of the document and others noted perceived redundancies. Additionally, there were suggestions to include practical examples within the document. Several respondents mentioned that a code of conduct alone cannot create data integrity; instead, there must be a culture of integrity. PDA is already moving to address many of the suggestions. Another task force is focused on culture within pharmaceutical manufacturing and has previously published the results of a survey (1). Building on these initial results, this Quality Culture Task Force has completed a pilot program to measure quality culture at more than 40 participating companies and expects to publish these results in 2018. The PDA Data Integrity Task Force also expects to publish technical reports on data integrity in 2018, one for laboratory systems and another for manufacturing systems.

Conclusion

Based on the positive results of this survey, the PDA Data Integrity Task Force will continue its work to develop additional tools and resources for the pharmaceutical industry. The Code of Conduct remains available for download.

Reference

1. Patel, P., et al. “Quality Culture Survey Report.” PDA Journal of Pharmaceutical Science and Technology 69 (2015) 631–642.