Balancing efficiency with ethical practices
By Richard Prince
That which is ethical will always be legally defensible. Conversely, that which is technically legal may not always be totally ethical. An ethical company is one that is interested in the relentless pursuit of improving the quality of its systems and processes because it is morally right. An ethical company understands and balances the need to economize without jeopardizing the rights of consumers to consistently receive safe and efficacious products.
The Good Manufacturing Practice (GMP) regulation as delineated in the Code of Federal Regulations (21CFR) establishes the minimal requirements for manufacturing drugs, devices and other products. Management is legally obligated to comply with this regulation. We are also aware that financial analysts can sway the market into precipitously dropping the value of a firm`s stock owing to “disappointing” earnings. A dual reality thus exists for corporations. On the one hand, there is a fiduciary responsibility to maximize shareholder value. On the other hand, there is a legal responsibility to ensure that manufactured goods are consistently being produced and that they possess the predicted (and filed) quality attributes. The pressure to streamline operations to fuel efficiency gains must be done without sacrificing the quality of product batches.
Managers are often faced with the responsibility and burden of making difficult choices on what manufacturing systems should be improved and what systems should be left alone at a given point in time. There is sharp competition for the allocation of resources as it pertains to improving operations efficiency or compliance rigor.
Quite apart from selecting and prioritizing quality improvement projects, there is the opposite paradigm which exists in some circles that is fundamentally more disturbing. It is self-evident to state that public corporations serve, ultimately, the shareholder. The goal is to increase profits on a regular basis. To an unethical firm, this may mean gutting a quality-centered function because it will help guarantee increased short-term profits. While this is short-sighted from a compliance perspective, we should not be surprised if some executives act in this manner if this is the basis for how they are rewarded by their employers. But, how can we circumvent this reality?
Physicians are bound by a code of ethics called the Hippocratic Oath. Lawyers are also bound by a code of ethics. Is there a common code of ethics to bind pharmaceutical professionals of all stripes, e.g., scientists, operators, engineers, regulatory specialists? It`s not clear to me that we have such a code.
A firm has an intrinsically variable test method. This method is deemed by the firm to be validated. The method routinely generates passing results and product batches are released, in part, on these data. On occasion, the test method generates discrepant results casting doubt on the particular quality attribute of the product. The firm conducts a set of re-tests. While it is obvious that there is sufficient scientific room for differing on what constitutes an acceptable, pre-defined re-testing regime, there should be no disagreement on this point: If a test method is good enough to be used as a platform for releasing products to the marketplace, it must also be used to potentially reject batches. Testing quality into the product is now officially interpreted by the U.S. government as being illegal in the aftermath of the Barr decision. It is also morally wrong to try to trick the test system into eventually giving the result that you wanted to see all along.
If a firm was producing product at the same time that facility renovations were underway near the production line, would that constitute merely a significant departure from GMPs, or suggest a greater problem? Would it be unreasonable to suggest that the site`s quality function failed in its core (ethical and legal) mission to assure that all of the manufacturing systems and controls were operating in place during the time of manufacture?
In a final example, let`s say that there is a noticeable spike in the non-viable particulate count in the sterile core. What criteria are to be used for determining whether or not the product batch should be rejected? It all depends, to borrow from FDA`s famous phrase. Were all of the other critical manufacturing and environmental systems and controls acting properly? Or, were there any other indicators of system or process decay? If there was any significant doubt on the quality of a batch, it would be both prudent and ethical to reject the batch even if you could make a legal case that the batch was salvageable.
Perhaps, the following can serve as a model for ethical decision-making.
1. I will properly train my people so they can fully succeed at their jobs.
2. I will fully understand and consistently control my processes.
3. I will prove that my people are trained and that my processes remain controlled.
4. I will release product because I know it is right, not because I hope it is right.
Richard Prince, Ph.D., is president of Richard Prince Associates Inc. (Short Hills, NJ), a compliance and technical based consultancy, and an officer of Microgen, a provider of quality disinfectant-cleaner products. He can be reached at (973) 564-8565, fax aat (973) 564-8731 or e-mail: [email protected].