It is important to take risks in any business endeavour. Every time investors and entrepreneurs fund a start-up, they take risk. Even business executives take risk every day when they take decisions about which services, products, people and ideas to advance within a company. No doubt, risk taking can be extremely profitable. However, excessive risk taking in the pharmaceutical industry can have devastating results. Most importantly, excessive risk taking compromises consumer safety. Numerous small- to mid-size pharmaceutical manufacturers have shut down due to product recalls, delays and enforcement actions by the Food and Drug Administration (FDA). Therefore, risk must always be tempered by caution in the pharmaceutical industry and the only way to do that is by using a robust pharmaceutical quality system founded on the latest FDA guidance.
Quality should never be an afterthought. Enforcing an effective quality system requires up-front costs and it is extremely important to put in place an effective quality system at the initial stages of product research and development as although the quest of quality is a costly line item on a business plan or financial statement, failure to enforce the same has even costlier effects on the bottom line.
According to the FDA’s latest guidance, an efficient pharmaceutical quality system should help check compliance with cGMPs by centring on:
- Risk management
- Quality assurance
- Quality management
- Quality risk management and evaluation analysis tools
- Preventive action
- Continuous improvement
The most recent guidance does not replace FDA’s previous regulations that necessitate every pharmaceutical quality system to incorporate Standard Operating Practices (SOPs), adequate training systems and personnel, and an efficient system for recordkeeping. In fact, the latest guidance is simply proposed to deal with advances in quality systems, risk management approaches and manufacturing technologies, developed since 1978. It is also directed at harmonizing the cGMPs with various extensively used quality management systems, together with the FDA’s medical device quality system regulations. The necessary framework required for implementing risk management efforts and continuous improvement in the drug manufacturing process, can be derived by developing a modern, quality system approach.
Although a culture of quality should pervade within the entire establishment, management plays a very crucial role in the design, productive functioning, management and implementation of a modern quality system. The management must express strong support for quality systems besides aligning the quality system plan with the organization’s strategic plan. Moreover, it’s necessary for senior executives of pharmaceutical manufacturers to promote internal communication regarding quality issues and to support the production, manufacturing and quality activities required for producing quality products.
So what exactly does a modern pharmaceutical quality system comprise? The modern pharmaceutical quality system basically has the following six subsystems:
- Production System
- Quality System
- Facilities and Equipment System
- Materials System
- Laboratory Controls System
- Packaging and Labelling System
The quality subsystem is the foundation for the other five manufacturing subsystems. It aids them to achieve compliance. Each of the six subsystems has an effect on the others and they all work jointly to systematically produce a quality product. However, it’s crucial to recognize that none of the subsystems individually equate to a functional group in a manufacturing facility or an organization. For instance, the Materials System doesn’t simply relate to warehouse personnel. It includes the warehouse personnel who obtain, store and handle and components and distribute final products, and also includes the buyers who purchase raw materials from qualified vendors; the manufacturing workers who ask for and receive components and transfer the final products to the warehouse. It also includes the quality assurance specialists who are in charge of component and lot release; and finally the quality control workers who do the sampling and testing of products and components.
Organizations with strong quality systems meet and exceed the cGMPs and also enjoy various other advantages, like better process and product understanding for improved decision making; ability to manage changes to prevent unintentional consequences; continuous improvement; minimized product variability; reduced costs due to fewer rejections, investigations and deviations; improved test method accuracy; minimized product costs and loss associated with disposal, scrap, recalls and rework; decreased labour costs related to automation of manufacturing processes; and reduced downtime with more dependable equipment and less repair interruptions.