Pharmaceutical Quality Management is a comprehensive concept, which covers all matters, which independently or jointly influence the pharmaceutical product quality.
In totality this concept defines an organized arrangement made with the purpose of ensuring that medicinal products are of the quality required for their anticipated or intended use. Therefore Good Manufacturing Practice incorporated in Quality Management System (QMS).
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| Pharmaceutical Quality Management System: An overview |
Management has the responsibility to make sure QMS are
set up in such a way that ensures state of control, for;
- Good manufacturing practices,
- Stockholder value,
- Achieving Goals,
- Continual improvement.
There are number of companies which are under consent decrees or that have obtained FDA warning letters indicates that management supervision of cGMP compliance is a continuing and significant problem on the marketplace.
Companies have been unprecedented impact, loss of brand loyalty, stockholder suits, and reputations. Sooner or later, the warning signs unheeded were unnoticed, or rationalized away.
This article describes the issues that might affect the ability of management to discover the signs of cGMP compliance issues that are important and provides suggestions on the way to gain control over this portion of the business. Overlooking of Pharmaceutical Quality Management System may impact the trustworthiness of a brand.
There is a Perceived disconnect between the company and cGMPs - Not only there is disconnect that is perceived, but cGMPs are viewed as an obstacle. There is no impediment to devoting attention to anything compared to question the value, or, at best, thinking that it a burden for someone to endure.
It translates into activities and language that are detected and emulated by individuals, when this is a belief of those in authority. With time, that view is widely adopted and becomes a part of the business culture which influences the way daily work is conducted.
The disconnect might sound something similar to this! i.e.
We sometimes cannot follow procedures. We've a business to run. The validation results were marginal. We may improve the process later. We frequently see this manufacturing problem. We routinely rework and 100% inspect. That test result is barely outside the spec. We know its good product to release. FDA didn't cite us for that. We must be okay. We cannot shut down for preventative maintenance.
We've to build inventory. Everybody eventually receives a warning letter and gets fined. Defending the company worth of cGMPs can only be successful if direction really believes it's true. Sadly for many in leadership positions, that understanding isn't component of their education or experience.
At the best, their background might include a training course or seminar, however their everyday experience with the pharmaceutical quality assurance and cGMP compliance purposes are the frustrating obstacles to release product to market. Therefore, what may be done to win the minds and hearts of direction to adopt the company value of cGMPs?
The response is to put forward a rational argument which cGMPs are a company enabler and also to integrate this belief in the company’s formal worth statement, new employee orientation, and ongoing training.
Nevertheless, this requires a more profound comprehension of the basic principles of cGMPs and recognition that they're no different than those of the company. The rational argument goes like this: Patients take the individual dose, not the average sometimes every day for their whole life.
We hope this article help you to understand the importance of Pharmaceutical quality management system, This article describes the issues that might affect the ability of management to discover the signs of cGMP compliance issues that are important and provides suggestions on the way to gain control over this portion of the business.
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