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The QA Pharm

FDA Compliance

Essentials for Sustaining an Operational Pharmaceutical Quality System

The quality management triad

Published: Wednesday, August 13, 2014 - 10:15

After nearly 20 years helping the biopharmaceutical industry to regulatory enforcement by implementing an operational and sustainable quality management system, I have come to the conclusion—at the most fundamental level—that there are three quintessential elements required for success. I call them the quality management triad.

Quality governance

Quality governance is the first element. This is the body that provides:
Vision. The aspirational view of the future, and how quality management is integral to the business strategy.
Leadership. The top business unit and functional heads who motivate, align, plan, and engage the organization toward its quality goals.
Standards. The policies and standards that are endorsed by leadership that establish the quality requirements.
Oversight. The communication channels and forums that provide leadership with direct visibility of product quality, and compliance risks and trends, to make effective data-driven decisions.

Pharmaceutical quality system

The second element is the pharmaceutical quality system (PQS), which is the Guideline ICH Q10—“Pharmaceutical Quality System” term for the quality management system. The PQS does the following.
• Establishes the document architecture: This is the hierarchy of the official, approved, written instructions and executable records.
• Implements the procedures: These are the processes—the “how”—to apply the requirements of the standards to your operation.
• Maintains control: Quality is about controlling variation, and the PQS establishes your intentional and consistent ways of working to control variables, including the human variable, to operate in a state of control.
• Includes the records that capture the product history as well as the manufacturing and environmental information that surround it.

Quality system ownership

The third element is quality system ownership, which is the specific application of the concept of business process ownership that sets expectations and accountability for the constituent parts of the PQS. Ownership includes responsibility for:
Execution. The daily management of the quality processes described in procedures to ensure they work and are being followed.
Maintenance. To ensure that the quality process remains current with regulatory requirements and industry practices, and remains applicable to your changing business.
Performance. The measurement of how well the process is working and being managed, as well as the problems and opportunities the process is detecting.
Escalation. The identification of unacceptable conditions or events that puts the patient and the business at risk, taking the immediate actions necessary to mitigate the risk, and making recommendations for permanently solving the problem.


At the center of the triad is the quality function, whose responsibility it is to engineer the processes for these three parts, and to ensure that they work—and work together effectively.

To be clear: Quality is everyone’s responsibility. But much like “safety” is everyone’s responsibility, it is quality’s responsibility to establish the ways and means of the quality management triad, and to report on the effectiveness of the processes and manage risks.

Why is the quality management triad important?

The pharmaceutical industry is a dynamic business environment. Acquisitions, operational realignment, portfolio changes, manufacturing relocation, facility repurposing, and organization restructuring and integration are among the strategies to increase stockholder value. These continual changes affect the quality management system, and like any other aspect of the operation, it must be managed to remain effective and relevant.

Take this hypothetical example of the single-ingredient, solid oral-tablet manufacturer that constructed a dedicated facility for its new product.

Later, high-potency, multi-ingredient tablets were introduced into this facility as line extensions. The facility was then expanded to manufacture oral liquids and eventually retrofitted to produce oral suspension products.

Plans were being made to introduce parenteral drugs into the facility when the decision was made to enter into an agreement with a contract manufacturing operation—a CMO—for that technology, which was the firm’s first venture into a third-party partnership.

All the while, volumes were increasing, markets became global, and the company turned to a 24/7 operation to keep up with demand. The increased profitability was directed toward the development of promising new drugs, while operating expenses were reduced and tightly controlled to fund new initiatives.

Although this was great news for investors and employees, an unintended consequence was quietly undermining the business. The pharmaceutical management system had not evolved with the business, and was no longer capable of reliably detecting and managing product quality and compliance risks.

“Loss of management control” was the theme of the series of FDA 483 warning letters and the eventual warning letter when the site was fraught with recurring manufacturing deviations and missed target dates to the FDA for solving the problems.

Although this is a hypothetical case, many people identify with some parts of this story when I share it.

Unfortunately, the quality management system is often viewed as a resilient tome of instructional content with little susceptibility to changes to the business. Nothing could be farther from reality.

Quality professionals across the industry who have looked back at their past quality problems and regulatory enforcement action, say—ironically—that their quality management system was a victim of their success.

Whatever the environment, the quality management system must be managed to ensure that it is fit-for-purpose, and that it continually serves and protects the business.

What are your thoughts? How mature is the quality management triad at your company?

First published in August 2014, on The QA Pharm.


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).