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.
That?s why the FDA created an example of a quality systems model in the Quality Systems Approach to Pharmaceutical cGMP Regulations. This document will help pharmaceutical companies implement an efficient system that will help them meet those regulations. A major component of this document is the management responsibilities, and here we will discuss that component and the possibility to automate any associated 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 also be reasonably responsible for all aspects of quality system maintenance and taking charge of the data analysis and many of the decision making issues. Unfortunately, many managers will spend their time on the early stages of the quality system, which are usually tedious and administrative. Many of those stages could easy be taken care of by an automated system.
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.
One other managerial responsibility is to ensure that the quality systems line up with the manufacturers strategic plans. It doesn?t matter what kind of quality system you are dealing with, you have to understand that it is not a stand-alone system. Every in the company is affected by it. That?s why it is critical to line up your plans with the requirements and systems already existing throughout the company.
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.
It may be hard to cope with all the managerial responsibilities one can have in the pharmaceutical industry, but a good quality management solution can make things a lot easier. That?s all you need to consolidate your tasks and increase efficiency and become a more competitive company.