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The QA Pharm

FDA Compliance

Management Responsibility for GMP Oversight and Control

Do you know where your daily operation stands at any given moment?

Published: Monday, December 7, 2015 - 17:06

Historically, the Food and Drug Administration (FDA) has cited the Supreme Court decisions of United States v. Dotterweich (1943) and United States v. Park (1975) as Federal Food, Drug, and Cosmetic Act (FDCA) legal cases that establish that the manager of a corporation can be prosecuted under the Federal FDCA, even if there is no affirmation of wrongdoing on the part of the manager individually.

In the Dotterweich case, the jury found Dotterweich, the president and general manager of a drug repackaging company, guilty on two counts for shipping misbranded drugs in interstate commerce, and on a third count for shipping an adulterated drug. One dissenting judge of the Circuit Court of Appeals reversed the decision on the grounds that only the corporation was the “person” subject to prosecution, thus protecting the president personally. But the Supreme Court reversed the decision, thus holding Dotterweich individually responsible, not just the manufacturer. Justice Felix Frankfurter delivered the opinion of the Court: “... under § 301, a corporation may commit an offense and all persons who aid and abet its commission are equally guilty….”

In the Park case, the chief executive officer was found guilty on all counts involving food held in a building accessible to rodents and being exposed to contamination by rodents, resulting in the adulteration of the food within the meaning of the FDCA. Park’s defense was that he had an organizational structure responsible for certain functions to handle such matters. However, evidence from inspections of multiple locations indicated the same problems and inadequate system for which he had overall responsibility. Chief Justice Warren Burger delivered the opinion of the Court: “... by reason of his position in the corporation, responsibility and authority either to prevent in the first instance, or promptly to correct, the violation complained of, and that he failed to do so... the imposition of this duty, and the scope of the duty, provide the measure of culpability...”


More recently, Public Law 112-144 (July 9, 2012) called the Food and Drug Administration Safety and Innovation Act (FDASIA) added to the definition of current good manufacturing practice (CGMP) in the Food and Drug Cosmetic Act (Section 501, 21 U.S.C. 351) to explicitly include management oversight of manufacturing to ensure quality. Section 711 of FDASIA states: “For the purpose of paragraph (a)(2)(B), the term ‘current good manufacturing practice’ includes the implementation of oversight and controls over the manufacturing of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the manufacturing of drugs, and finished drug products.”

The addition of oversight and controls to the definition of CGMP has strengthened the FDA position with specific language for management’s responsibility for oversight and control as a requirement in the Act. The question remains of how to practically and operationally perform this responsibility. The following model describes essential elements of a CGMP management system for oversight and control.

Management system

The implication of the effect of CGMP noncompliance on the business is not theoretical. There are ample examples in the pharmaceutical industry where ineffective implementation of CGMP systems resulted in the loss of control that materially affected product quality, which, in turn, affected inventory and patient supply. Establishing a pharmaceutical quality system that effectively implements the CGMPs is the means for maintaining a state of control—the fundamental intent of these regulations.

Management does not assume positions of responsibility with the intent of neglecting CGMP compliance. However, management may not enter the top position fully equipped to assume responsibility for CGMPs in a practical way. Management may delegate all CGMP matters to the quality department and take a hands-off approach, thereby relying on this function to bring matters to its attention at their discretion. Such passivity leads to hearing bad news when it is far too late to contain and resolve the problem in the most cost-effective way with least risk to public safety.

Likewise, some quality departments may not be adequately equipped to bridge the space between top management and daily operations with effective structures and processes that enable management to exercise its responsibility for CGMP oversight. Too often the default position is to rely upon the outcome of regulatory inspections. But as one might expect, a good outcome can give a false sense of security, and a poor outcome can be viewed as the exhaustive list of problems.

As in any area of the business where risks must be managed, there is no better approach than having an intentional management system in place that provides actionable data to know internally where your daily operation stands at any given moment.

First published Oct. 30, 2015, on The QA Pharm blog.


About The Author

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The QA Pharm

The QA Pharm is a service of John Snyder & Co. Inc., provider of consulting services to FDA-regulated companies to build quality management systems and develop corrective actions that address regulatory compliance observations and communication strategies to protect against enforcement action. John E. Snyder worked at the lab bench, on the management board, and as an observer of the pharmaceutical industry for more than 30 years. His posts on The QA Pharm blog are straight talk about the challenges faced by company management and internal quality professionals. Synder is the author of Murder for Diversion (Jacob Blake Pharma Mystery Series Book 1).