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Helping JGXP Readers to be Proactive
Author: Paul L. Pluta

Past “From the Editor-in-Chief” commentaries have discussed the objectives and approaches of the Journal of GXP Compliance (JGXP). In brief, we aim to provide readers with useful information based on scientific and technical principles whenever appropriate. We strive for dialogue with our readers to learn our reader’s needs. Dialogue with readers helps us to be relevant, useful, and meet your expectations.

JGXP Objective
Our objective in providing information is to support and assist in the variety of situations in which our readers may be involved. These range from significant work events to practical information for individual personal growth. There may be individual lot release events with substantial financial impact, long-term policy decisions, organizational planning, preparation of specific procedures, specific technical topic discussions, compliance problem investigations, and so on. Many of these are “reactive” situations (i.e., reacting to some specific occurrence). Many, however, may be “proactive” situations involving considerations at an organizational level, project level, or involving a manufacturing process or equipment change.

Proactive organizations are successful. Just as in business, compliance organizations must be proactive in order to survive. McDonald’s was proactive in transitioning their menu to include a health-conscious clientele. In contrast, companies who experienced recurring toxicity events in the global marketplace due to ethylene glycol contamination obviously were not. Most compliance situations are reactive—we have a problem and we react. We all know of situations in which problems were highly predictable, but regrettably there was no proactive effort to prevent the failures.

Successful compliance organizations must be aware of evolving requirements to ensure that they are compliant with industry and regulatory expectations. A proactive quality group will be sure that technical work is thorough, sources of variation have been identified, control methods have been developed, and so on to prevent failures from happening. Proactive groups will also ensure that adequate preparatory work has been done to be sure that process changes or equipment changes are successful. Proactive groups will ensure that the compliant state is maintained through change control and related measures. Proactive internal audits will search for problems before they occur. The aforementioned activities should be conducted and prioritized with consideration for the risk involved.

The 2008 US Food and Drug Administration’s draft validation guidance describing the lifecycle approach to process validation provides a model for a proactive approach to compliance. Certain companies viewed process validation as a singular, distinct, one-time event. Development efforts were not thorough or complete, and validation was initiated prematurely. If validation was successful, there were inadequate efforts to monitor, confirm, and maintain the validated state. Compliance programs can be structured in the same way. There should be sound approaches to the quality systems in an organization, and once established, there should be continuing efforts to monitor and maintain compliance. These efforts should be ongoing and enduring, and should lead to proactive continuous improvements.

JGXP Articles
Quality units can “set the tone” for a proactive approach to compliance in their organizations. Several articles in this issue of JGXP are particularly supportive to such a proactive approach, such as “Hand Washing, Hygiene, CGMP, and Science,” by Scott Sutton, Ph.D. This topic was actually suggested by a reader who related his concerns about validating various aseptic and “clean” processes when personnel were not adequately performing fundamental tasks, such as washing their hands. Showing personnel that their hand washing was inadequate by means of a fluorescent marker significantly and effectively improved performance of this mundane activity. Training and ongoing refresher training as part of an organizational culture that emphasizes and rewards excellent job performance are key in these situations. These and many other articles published in JGXP have a common theme: Basic understanding of products, processes, and systems in advance of use and ongoing monitoring to maintain compliant performance.

Proactive compliance organizations are successful. We encourage the proactive use of the information provided in JGXP to improve compliance and prevent problem situations from occurring. Compliance groups should work closely with technical development and engineering groups throughout the product lifecycle. This general approach should also be applied to all quality systems. Activities must be conducted under the umbrella of risk analysis. The effort involved in these endeavors will vary with the management and culture, but there is no doubt that this is the direction that should be taken. Preventive action needs to occur after problems are corrected, but it would be much better to prevent problems from occurring in the first place. Compliance groups should be proactive to accomplish this end.

ABOUT THE EDITOR-IN-CHIEF
Paul L. Pluta, Ph.D., has extensive pharmaceutical industry and university academic experience and has been involved with the journal as a writer and editor for several years. He may be reached by e-mail at paul.pluta@comcast.net.

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