By : Alberto Sanchez
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.
According to the FDA's Quality Systems Approach quality system model, senior management should demonstrate commitment to developing and maintaining the quality system. The development of a quality system takes time and dedication. No matter how much a manager may know about the complexities and the "ins and outs" of various quality system models, he or she will invariably need to commit to the development of the quality system itself.
Management should be responsible (to reasonable degree) in all aspects of quality system maintenance and will often be in charge of data analysis and subsequent decision making issues. However, managers often spend most of their energy on the early stages of the quality system which are usually nothing more than tedious administrative tasks. This is unfortunate since many of the stages of quality system maintenance are prime opportunities for automation.
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.
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. An automated process will allow pharmaceutical companies to essentially connect quality, compliance and everyday procedural processes with applications that are launched from one platform.
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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