In the pharmaceutical industry, many companies often find it difficult to find a quality system model they can rely upon, as well as meet all of the required FDA initiatives.  Because of these tight FDA restrictions, such as the FDA’s cGMP initiative and 21 CFR Parts 210 and 211 regulations, as well as the FDA’s Critical Path initiative, it can be very difficult for many pharmaceutical companies to come up with a reliable and cost-effective quality system.  This is why many pharmaceutical companies all over the world are trying their best to come up with different quality system methods that are not only reliable, but also meet all pending government regulations.

In order to create a quality system that not only fulfills the company’s needs, but meets all the regulations/requirements listed above, many quality engineers are looking for outside help to come up with the best quality system possible.  And one of these potential sources is none other than the FDA itself.  The FDA,has a Quality Systems approach model that may help many companies provide the building blocks from which to build their systems.  Here is what they have to say.

The FDA has a quality systems model focusing on four main categories: management responsibilities, resources, manufacturing operations, and evaluation activities.  However, their main focus out of these four is on management responsibilities within a quality systems approach.  This means that it is up to senior management to develop such a system that not only demonstrates commitment to develop and maintain their system, but also takes responsibility for their success or failure.  Regardless of how much a quality control manager may know about the intricacies and complexities of the various quality system models they’re using, they must be committed to developing the best quality system possible, as well have the responsibility for properly maintaining the system.

According to the FDA, maintaining a reliable quality system breaks down into the following 5 steps: observation of the quality system, identification of deviations and nonconformance events, report, proper analysis, and taking the appropriate action.  It is vital that management have clear responsibilities when covering all aspects of system maintenance including data analysis and reporting any irregularities in the system.  While it is common for quality system managers to spend most of their time and energy on the stages with the heaviest burden, mainly steps 2 and 3, managers need to address all stages with appropriate time and energy.

Any life sciences consulting firm will tell you that a quality system, regardless of its type or complexity, is never fully an entity unto itself.  For any quality system to work correctly it needs to have managers on site that are not only familiar with the system, but are dedicated to its maintenance and ongoing success.  This is why it is critical that any quality system plans not only meet the goals and standards of the pharmaceutical company, but also be aligned with the company’s system management approach as well as other departments in the company.

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