Pharma Quality System – Essay Example
The paper "Pharma Quality System" is an excellent example of a business essay.
A Quality System is the organizational processes, structures, resources and procedures used in manufacturing, especially in pharmaceutical products in accordance with applicable regulations. In the pharmaceutical industry, the quality control is a very important issue especially in manufacturing of the product and there are very many procedures and rules governing this area. They have introduced quality system assurance control. This entails quality planning, quality control, quality assurance and quality improvement for achieving consistent product quality.
The main aim of the quality system is to achieve product realization, establish and maintain a state of control and facilitate continual improvement across the different lifecycle stages in manufacturing. The main component of product lifecycle includes; pharmaceutical development, technology transfer, commercial manufacturing, and product discontinuation.
In the quality control system, there is a need for an external auditor who understands both company structures, administrative system, and the industrial policy so that they can fix the quality system within the firm, this will ensure the safety of the product produced and the general well being of the public.
There are mainly four aspects to consider when fixing the quality control system; they include Process Performance and Product Quality Monitoring, Corrective Action and Preventive Action, Management change, and Management Review of Process Performance and Product Quality. The quality control board usually imposes strict rules and regulation on all players in this industry and any violation of this quality system control come with very stiff penalties including the practitioners losing their job.
These external players contribute a lot to the company and even the people managing this system must play with them. This aspect of external players in developing a quality system makes the managers so vulnerable and they are no longer managers but also being managed by external forces. To ensure consistency the system administrator should be reviewed continuously order to remain compliant and be able to efficiently produce a quality product in the market.