In the pharmaceutical industry, it can be difficult to find a quality system model that provides a rendezvous point to conform with the FDA’s cGMP initiative, 21 CFR Parts 210 and 211 regulations, the FDA’s Critical Path Initiative, ISO 9000 standards, and the requirements of foreign regulatory bodies.
The FDA, however, has created a quality systems model in the Quality Systems Approach to Pharmaceutical cGMP Regulations guidance document that can show pharmaceutical companies a high-functioning system that will help meet all of those regulations. One of the categories the document focuses on is management responsibilities, and we will discuss those responsibilities and the possibility to automate many of the associated administrative tasks.
The FDA?s approach to quality system models requires that senior managers are committed to developing and maintaining their quality systems. It takes time and dedication, and it doesn?t matter how much they may know about the complexities of a range of different quality system models, they will have to commit to working with their own quality system.
The management should be responsible for the various aspects of quality maintenance and taking control of the data analysis and the decision making issues that are related to it. Unfortunately, many managers get bogged down in these early stages of the quality system, which can be very tedious and repetitive. And most of those stages are the ones that are easiest to automate.
Quality management personnel in regulated pharmaceutical environments can take advantage of “automation benefits” by using software solutions. In short, these solutions should provide the data and trending technology that makes it easy to identify quality system deviations and nonconformance events. With effective automation technology, important responsibilities of quality system maintenance are still managed but tedious administrative can be automated.
Another responsibility for managers is to ensure that quality system plans are always aligned with a manufacturer’s strategic plans. A quality system-regardless of the type-is never an entity unto itself. It really is part of everybody’s business. That is why it is essential that the quality system plans of any pharmaceutical company meet with the goals and realities of other systems and processes that occur throughout the industry.
Sometimes it can be a bit difficult to get the quality system in line with the other processes in the other departments. Many companies simply have a tendency to be disjointed and subjective. If you can automate those processes, though, it will be much easier to get all the quality, compliance, and procedural requirements to connect.
In the pharmaceutical industry, it sometimes seems that the facets of managerial responsibilities 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.
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