Why is Quality System Design Crucial in Pharmaceutical Industry?

Why is Quality System Design Crucial in Pharmaceutical Industry?
September 05 08:31 2019 Print This Article

We’re living in an era where consumers are informed and knowledgeable than ever before. Especially, when it comes to the health sector, patients and their families are obviously not prepared to take any sort of risk. This is why pharmaceutical industries are trying to invest more and more on establishing result-driven Quality System Design that helps them produce highly effective and quality-controlled drugs in lowest possible costs.

According to Senieer – Manufacturer of Pharmaceutical Equipment, Quality System Design is basically the structure on which the Quality Management System (QMS) is established. Simply put, Quality Management System is the systematic implementation of quality standards to diversified business processes.

The significance of QMS is important to the manufacturing sector, particularly to the pharmaceutical industry where use of substandard machinery or low-quality material can significantly impact the patient’s health and wellbeing. In fact, it wouldn’t be incorrect if we consider QMS as the basic and the most essential element of effective production practices for pharmaceutical, biotech and other standardized sectors.

An effective Quality Management System is created by focusing on the organizational preferences, manufacturing processes and the prevalent quality policy. Noticeably, the quality policy in drugs manufacturing is mainly derived by taking into account the demanding regulatory laws and compliance standard procedures.

Steps Involved in the Quality System Design

In general, the organizations need to pay attention to the below listed steps in order to establish a fully functional and result-oriented Quality System Design for their organization:

  • Recognizing the organizational preferences
  • Explaining quality guidelines/policy
  • Comparing quality standards with ongoing business procedures
  • Applying the Quality Management System
  • Controlling QMS to detect any flaws
  • Revising strategies to make improvements in the QMS

Primary Features of Quality Management System

While formulating a QMS, there are some basic attributes that must be considered by the owners. By following these procedures, pharma companies can become more vigilant and quality compliant.

Standards and Procedures

This consist of the complete document containing details about the organizational requirements, quality guidelines and operating procedures that are in line with the current regulatory ecosystem. The term ‘standards’ refer to requirements while ‘procedures’ explain the process in which those standards must be applied. Both these aspects work in collaboration with each other to form a framework that could be further used in the process of decision making.

Quality Assurance

The role of quality assurance in pharma is crucial. It’s organization’s responsibility to adhere to regulations and detect any flaws at the same time suggesting measures that can help in the eradication of those weaknesses.

Performance Metrics

For any system to work flawlessly, it is important to outline criterion that needs to be fulfilled. The job of performance metrics is to define targets and make assessments from time to time to check the performance of the QMS.


In conclusion, Quality System Design plays a vital role in the success of any pharma company. It enables owners stick to the basic quality guidelines and revamp their procedures to ensure manufacturing of quality medicines and drugs.

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Nathaniel Little
Nathaniel Little

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