An important aspect of a pharmaceutical company is a robust quality management system (QMS) because it shows the company’s commitment to quality. This idea was introduced by the International Conference on Harmonization (ICH) Q10 Pharmaceutical Quality Systems and the USP/NF <1083.1>.
A QMS is defined as a set of interrelated or interacting elements such as policies, procedures, objectives, and processes. Senior management must confirm that the QMS considers all applicable guidelines and regulations and ensure that the required resources are provided to uphold pharmaceutical industry compliance. To guarantee success, communication flows within the organization must be timely.
In episode 24 of CMC.Live, Design Space InPharmatics had a variety of experts in the pharmaceutical industry who specialize in quality management. Susan Fasso states, “A quality management system provides an infrastructure for a company to ensure that the quality of their drug product complies with regulations and assures patient safety as its primary function.”
The development of basic QMS and quality systems from early in the development phases through to commercialization is advantageous to the company. The sooner the systems are developed and implemented, and the mindset and culture are inducted into the company, the more prepared the company will be for regulatory and health interactions in the future. This results in a better chance of successful product approval.
QMS encourages the mindset that ensures a company will have trained and qualified individuals who focus on quality throughout the product lifecycle.
The QMS should include a company’s quality manual, quality policy, mission statement, and the hierarchy of its policies, documentation, procedures, and work instruction. Commitment to the following cGMPs is conveyed in all documentation within the QMS.
Quality is not achieved by one person alone. The quality assurance team at DSI is comprised of various individuals with diverse backgrounds and experience. Everyone must be on the same page or a decrease in quality will occur. A QMS assists in maintaining the company line.
The sooner quality is implemented, the better. Bettina Kaplan states that you do not want to slap a Band-Aid on a process at a later time. Companies should have a QMS outlined, ready with a course of action. It is an all-hands-on-deck situation and should not be left to those on the frontline in factories creating products or the owners of pharmaceutical companies. Every person on the team affects the product in terms of quality, and QMS is effective on all levels.
QMS is one of the most significant elements of a product and should be considered for the process of submission for approval. The integrity of the data is also crucial. As Kaplan states, “If the data going in is garbage, you're going to get garbage out. You have no idea if that data is beneficial.” Regardless of the scale of the facility (virtual compared to brick-and-mortar) or company, QMS must be taken seriously and implemented as soon as possible to ensure a successful product launch.
About DS InPharmatics LLC
DS InPharmatics (DSI) provides regulatory, technical, and project management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.
Since 2007 we have provided our clients with innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence. Whether advocating CMC strategy, directing CMC operations, or developing CMC submission content that represent the best interests of emerging biotech, we focus on the critical CMC issues and build programs that enhance development.
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