A Recommended Quality System Model: Responsibilities of Management and Techniques for Automation in Regulated Pharmaceutical Environments

In the pharmaceutical industry, it can be difficult to find a quality system model that provides a rendezvous point for conformance (either directly or indirectly) with the FDA’s cGMP initiative, 21 CFR Parts 210 and 211 regulations, the FDA’s Critical Path Initiative, ISO 9000 standards and/or the requirements of foreign regulatory bodies.
The FDA however presents a potential quality systems model in the Quality Systems Approach to Pharmaceutical cGMP Regulations¹ guidance document that may provide the building blocks that pharma companies need to begin or continue developing a high-functioning quality system that will help meet all of the regulations/requirements mentioned above. The FDA’s suggested quality systems model is divided into four main categories:

• Management Responsibilities
• Resources
• Manufacturing Operations
• Evaluation Activities

The focus of this article will be on the first category: management responsibilities---and will comment not only the stated responsibilities of management (provided by the guidance document itself) but on the possibilities for the automation of many tasks (often administrative) that are associated with pharmaceutical quality systems management.

Responsibilities of Management Personnel in Regulated Pharmaceutical

Environments
According the FDA’s Quality Systems Approach quality system model, management personnel in pharmaceutical environments should be responsible for the following:

Responsibility #1: "Senior Management Should Demonstrate Commitment to Developing and Maintaining their Quality System"²

The development of a quality system takes time and dedication. No matter how much a quality manager may know about the complexities and the "ins and outs" of various quality system models, he or she will invariably need to demonstrate a commitment to the development of the quality system itself. Management personnel also have the responsibility of quality system maintenance.

Quality system maintenance can be described in five stages:

1. Observation of quality system
2. Identification of deviations and nonconformance events
3. Reporting
4. Analysis
5. Appropriate Action

Management should be responsible (at least to reasonable degree) in all aspects of quality system maintenance and will often carry the most important responsibility of data analysis and subsequent decision making (stage four). However, managers often spend most of their energy on stages the heaviest burden at stages two and three and even on stage one which essentially (at least below the strategy level) are nothing more than tedious administrative tasks. This is unfortunate since the first three stages of quality system maintenance are prime opportunities for automation.

The benefits of automation are obvious:

1. More time for analysis and related research
2. Less administrative responsibility

Quality management personnel in regulated pharmaceutical environments can take advantage of "automation benefits" by searching for software solutions that can be an "observer" of a company’s quality system. In short, these solutions should provide the data and trending technology that makes it easy to identify quality system deviations and nonconformance events. The solution(s) should also provide sophisticated auditing software and should also allow for the easy creation of reports that reflect data trends. With effective automation technology, the most important responsibilities of quality system maintenance are still in the hands of management but timely and tedious administrative tasks become a "thing of the past."

Responsibility #2: "Quality System Plans Should be Aligned with a Manufacturer’s Strategic Plans to Ensure that the System is Part of the Manufacturer’s Mission and Quality Strategies."³

A quality system—regardless of the type—is never an entity unto itself. A quality system has its metaphorical noses in everybody’s business. That is why it is essential that the quality system plans of any pharmaceutical company be melded into the goals and realities of other systems and processes that occur throughout the pharmaceutical environment. It can be difficult however to align quality system management with other processes and departments (even beyond manufacturing) because departments have a natural tendency to be disjointed and subjective.
Automation—if the right solution(s) are provided--can allow pharmaceutical companies to essentially connect quality, compliance and everyday procedural processes with solutions that are launched from one platform (management should look for a web-based platform). The benefits of one-platform, centralized automation are at least two-fold:

1. Faster and more effective communication between departments
2. Less quality system errors due to manufacturing and quality disconnects

Conclusion
In the pharmaceutical industry, it would seem that the facets of managerial responsibility are innumerable. However, modern quality management solutions (GxP management solutions for instance) have been designed to consolidate and considerably ease the efforts required by pharmaceuticals management personnel.

Additional Reading
Adopting Technology in the Life Science Industry: Why is it Taking so Long?

Reference
1-3http://www.fda.gov/CDER/guidance/7260fnl.htm

Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. To learn about automated quality system solutions and integrated quality management software, please feel free to contact a MasterControl representative.