A robust Quality Management System (QMS) is an important aspect of a Pharmaceutical company as it demonstrates a company’s Senior Management commitment to Quality. This was rolled out by the International Conference on Harmonization (ICH) Q10 Pharmaceutical Quality Systems and the USP/NF <1083.1>. A Quality Management System is defined as a set of interrelated or interacting elements such as policies, objectives, procedures, and processes. Senior management should ensure that the QMS takes into account all applicable guidelines and regulations. Additionally, Senior Management should assure that all the necessary resources are provided to maintain compliance to the pharmaceutical industry. The key to making this successful is assuring communication flows are timely within the organization.
In episode 24 of CMC.Live, Design Space InPharmatics had a number of experts in the pharma 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.”
Developing the basic QMS & Quality Systems from early in the development phases through to commercialization is beneficial to the company. The earlier the systems are developed and implemented and the culture and mindset are infused in the company, the more prepared the company will be for future regulatory and health interactions, leading to a better chance of having a successful product approval.
QMS instills the mindset that assures that the company will have qualified and trained individuals who focus on “Quality” throughout the lifecycle of the product.
The QMS should include your Quality policy, Quality manual, your mission statement, the hierarchy of your documentation, policies, procedures, and work instruction. Commitment to following cGMPs are expressed in all documentation within the QMS. Quality is not a one man show. Even seen at DSI, the quality assurance team consists of a number of people with differing backgrounds and amounts of experience. If everyone is not on the same page, quality will decrease. This is where a quality management system helps keep a company in line.
The earlier you implement quality the better off you are in the long run. Bettina Kaplan states that you don’t want to slap a band aid on it later. You want to have your QMS outlined and ready with a course of action. It is an all-hands-on-deck situation. It is not left to those on the ground creating products in factories or the big owners of pharmaceutical companies. QMS is effective on all levels and every person on the team makes an impact on the product in terms of quality.
QMS is one of the most important aspects of your product and it should definitely be kept in mind for the process toward submission for approval. Additionally, the integrity of the data is critical, 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 size of the company or the facility (virtual vs brick & mortar), QMS should be taken seriously and implemented as early as possible for a successful product launch.
To get more information on Quality Management Systems, tune in to Episode 24 of CMC.Live with our panel of Quality Assurance Experts!