What does a modern pharmaceutical quality management system look like?

Pharmaceutical industry is amongst the most astringently regulated manufacturing units, always work under the shrewd scanner of quality and regulatory authorities. Pharmaceutical quality management system ensures us about the utmost level of quality, safety, purity and efficacy of finished product. Currently the Pharmaceutical industry is passing through the paradigm shift from quality to risk management, because now the whole approach is proactive rather than reactive.

In Pharmaceutical industry, if risk has not been encountered properly could have devastating results; product delays, recalls, and enforcement actions by the Food and Drug Administration (FDA) have led to the demise of many small- to mid-size Pharmaceutical manufacturers.

According to FDA every Pharmaceutical quality management system should include SOP (Standard Operating Procedure), effective training management system and record keeping system.

Quality is not just a term or process, it should be permeate the entire organization. Management plays a very important role in the successful functioning, design, implementation and management of a modern quality management system. Not only should management align the quality management system plan with the company’s strategic plan, it must demonstrate strong support for quality systems. It’s essential for senior leaders of pharmaceutical manufacturers to encourage internal communication about quality issues and support the production, quality and manufacturing activities needed to produce quality products.

But what does a modern pharmaceutical quality management system look like? The quality management system is like a hub and five other manufacturing systems are connecting with it like a spokes.

Imagine the hub and spokes of a wheel. The quality system itself is at the center (the hub), but it is connected to five other manufacturing systems (the spokes).When you include the quality system as a hub at the center of it all, the five subsystems of a modern pharmaceutical quality system are the:

• Production Management System

• Facilities and Equipment Management System

• Laboratory Controls Management System

• Materials Management System

• Packaging and Labeling Management System

The quality management system at the center connects the five manufacturing subsystems and helps them to achieve compliance. Each sub system has an impact on the others and they all have to work together to consistently produce a quality product.

E.g. The materials management system does not only connects with the personnel working in warehouses who receive, store and handles components, raw materials and final product but also connects to the purchasers who buy the raw materials from qualified vendors, the manufacturing workers who request and receive components and transfer final product to the warehouses and quality assurance specialists responsible for batch release and quality control employees who sample and test component and products.

At the end organizations having effective quality management system will enjoy many benefits like: improved product and process understanding for better decision making; continuous improvement; the ability to manage change to prevent unintended consequences; minimized product variability; enhanced test method accuracy; reduced costs due to fewer investigations, deviations and rejections, minimized product loss and costs associated with scrap, disposal, rework and recalls; reduced downtime with more reliable equipment and fewer repair interruptions; and decreased labor costs associated with automation of manufacturing processes.