In this series, we explore the characteristics of an exemplary Quality practice, the benefits it brings to companies and patients, and how RegDev supports clients in establishing consistent standards and processes. 

What typifies an exemplary Quality practice and how do companies — and ultimately patients — benefit?

In the pharmaceutical industry, to implement and establish an effective Quality Culture and Quality Management System (QMS), robust quality practices are required. Such ‘practices’ ensure that the elements of an effective Quality Culture and QMS are effectively integrated and supportive of each other.  

There are differences between robust quality practice types. Some practices are more characteristic focused (e.g., having a good risk based QMS) and some practices are more behavior focused (e.g., following good cross-functional governance and oversight).  

What typifies an exemplary Quality practice may best be answered by evaluating the accumulative effect of all practices working together towards the goal of establishing and implementing the most robust Quality Culture and QMS combined. This approach not only benefits companies by allowing them to operate at their highest levels from a Quality and Compliance perspective, but it also benefits patients taking drug products that are developed and produced by companies who conduct operations to the highest level of Quality and Compliance possible. 

A robust Quality practice benefits patients taking drug products that are developed and produced by companies who conduct operations to the highest level of Quality and Compliance possible. 

What skill sets (both soft and technical skills) and knowledge are necessary to build an effective Quality practice?

Both soft and technical skills are both essential to an effective Quality practice. When focusing on soft skills, it’s important to hire employees, contractors, and vendors that are mindful in how they engage, interact, and work with people, whether that is in-person or via remote technologies.  

Similarly, technical skills and level of knowledge are crucial factors. For example, to be effective in supporting a project, it is essential that the applicable regulations, standards, and guidance documents are understood. This allows all parties to determine what level of GxP support is required, and in what order of priority. 

What aspects of a robust Quality practice are typically missing?

One common aspect of a robust Quality practice that may be overlooked is that a Quality Management System (QMS) should be established to support drug development activities, particularly in the pre-clinical and early clinical phase following the drug discovery phase.  

In parallel, new start-up bio-pharma companies oftentimes encounter additional, related problems due to a reduced level of understanding of applicable global regulations, standards, and guidance documents which need to be adhered to on a phase-appropriate basis. 

Supporting bio-pharma companies to address these types of unanticipated yet common problems, helping them to establish an acceptable phase-appropriate QMS, and ensuring that all drug development-related activities are conducted in adherence to applicable regulations, standards, and guidance documents, ensures successful outcomes are achieved. 

How do you go about establishing consistent standards and processes?

First, it’s important to gain a complete understanding of the landscape, focusing on drug/medicinal product candidates in scope of the project (i.e., product category and associated supporting science for the product).  

Second, it’s crucial to understand the development and commercialization work that has already been conducted to date for the product, and an understanding of the level of compliance of the QMS to support the development and commercialization work conducted.  

Finally, all parties (employees, contractors, vendors) should be aware of current regulations and standards which apply to the project.  

With an approach based on collaboration and partnership, RegDev provides a tailored approach and innovative solutions that address the quality and compliance issues that each of its clients face. 

What are the key factors that differentiate RegDev’s approach to Quality?

A unique factor that differentiates RegDev’s approach to Quality is the consistent dedication to supporting clients holistically. With an approach based on collaboration and partnership, RegDev provides tailored, innovative solutions that address the quality and compliance issues that clients face.  

Our team conducts its client support business with the highest standards of integrity and ethics, always striving to achieve the highest level of quality and drug/patient safety while securing and working with sensitive client information.  

RegDev specializes in process optimization of all GxP systems to improve effectiveness, reduce risk, and increase efficiency for clients during the drug development and approvals process. 

Do you have questions about our QMS services or our broader array of Strategic Drug Development, Independent Verification, or Risk Management offerings? Would you like to learn more about RegDev’s approach to projects? Get in touch to learn more about how we can partner with you to achieve your goals.