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. 

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.

Learn More….What is pharmaceutical Quality Management system for Pharmaceutical Industry?