Identifying Gaps in Quality Management Systems to Maintain GMP Compliance

For most companies, a system installed several years ago is, by default, the process used to get work done today. To remain current with FDA regulations, it is important to periodically review GMP (good manufacturing practice) compliance regulations. A natural product brand must have efficient quality management system (QMS) processes in place and adequately trained personnel to avoid pitfalls created through ignorance or misplaced frugality. GMP compliance is vital, not only because it is mandated, but also because food quality control (QC) is necessary to ensure food supplies are safe, of good quality and available for all population groups.

The purpose and requirements of GMP regulations are essentially broken into 21 core components per FDA. These fold into the six core elements of effective quality systems per FDA’s Compliance Program Guidance Manual:

1.       Quality systems

2.       Facilities and equipment systems

3.       Packaging and labeling system

4.       Materials system

5.       Production

6.       Laboratory control system

The trick is to have a battery of effective questions to ask across a diversely selected group to assess performance in these six general areas and, more specifically, in the 21 breakout areas. It is most useful to focus these questions in three primary groups that probe design performance, systems performance and business performance. While business performance is not mandatory to compliance standards, it is a good indicator of the convergence of quality with connected issues regarding operations, marketing, sales, competitive advantages, etc.

Examples selected of the 21 areas to assess may be change control, corrective and preventive action (CAPA), and document management. Each of these can be probed to provide a current state. When compared to a best practice, a balance is struck between regulatory acceptance and what would be best for a business. Questions from each of the three primary groups may include:

·         System design—procedures describe the process for recording initiation and evaluation of all changes;

·         System performance—records are maintained of all changes throughout the entire change process from initiation through closure; and

·         Business performance—the system and standards are in alignment with the company’s critical success factors. These are scored based upon a standard scale of one to five and plotted on an easily visualized graph.

As you evaluate the responses to these questions, the data can be plotted into an actions chart and given context for managing the path forward in terms of corrective actions, risk, responsibility, budget and timeline for completion.

Each of the 21 core systems dimensions of a total QMS system can be reviewed over time, and the data and subsequent actions folded into business plans for improvement.

This method has been used successfully at pharmaceutical and nutraceutical companies. It is easily adjusted to meet industry-specific needs. As with any aging system, a checkup is needed to make certain everything is working as it should. “Sharpening the saw," or staying on top of your QMS system, prevents surprises that can have significant consequences.

Hear Ken Peterson, director of development, quality and compliance consulting, MasterControl Inc., discuss “Identifying Gaps in Quality Management Systems for GMP Compliance" at SupplySide West on Tuesday, Oct. 7, at 10 a.m.

Ken Peterson is director of quality solutions at MasterControl with a strong background in both life sciences and engineering. He has more than 25 years of experience in consulting and organizational change, quality management and product development.