Personalized Solutions for the IndustryWed, 09/05/2018 - 09:47
Q: What are BPF, Part of QbD Group’s main lines of operation and core activities?
A: Our core business is advising and consulting for companies in the healthcare sector related to validation and qualification issues, especially for computerized systems. Additionally, we rent out measuring equipment, we offer legal advisory on sanitary regulation, provide implementation of quality management systems, perform risk analysis, provide in-house courses, do project management for GMP implementations and staff outsourcing and evaluation of infrastructure, equipment and staff. Fifty percent of our capital goes to BPF and the other 50 percent to Quality by Design (QbD), a Belgian company that focuses on the development, design and quality validation for biological, cosmetic and sanitary products. At first, we were distributors of QbD quality- control software Quality Kick, but then we widened our reach and changed our name to BPF, Part of QbD Group. This has helped us to access a new organizational level of training and knowledge.
Q: What types of systems do you validate?
A: The GAMP 5 guide from the International Society of Pharmaceutical Engineering (ISPE) outlines a classification of systems that require validation to guarantee that these systems do not negatively impact the quality of health-related products. We can validate a simple spread sheet or an enterprise resource planning (ERP) system or a SCADA computerized system. We have experience validating those systems related to product quality. Our team includes validation engineers who are biologists, pharmacists and computer and mechatronics engineers, contributing to the knowledge base that allows us to offer integral services.
We are also working with QbD on software development. Its main product is Quality Kick, an innovative program for quality management that has applications in the cloud and process adaptability, besides other systems like Lab Kick.
Q: In which healthcare segments does BPF, Part of QbD expect the greatest growth?
A: We have a greater presence in the pharmaceutical and logistics segments and our customer base includes four of the leading logistics companies for health-related products. As part of our strategy for 2018 and 2019, we expect growth in the medical devices, biologics and biotech segments.
Q: Healthcare is evolving toward the application of new digital technologies. What approaches are validation companies taking regarding this development?
A: Technology evolves so fast that regulations are often left behind. Today, there are technologies that impact people’s health but for which there is a lack on validation or testing methods. These technologies include artificial intelligence, virtual reality, nanotechnology and additive manufacturing. For example, 3D printing is applicable to drugs, medical instruments and tissue manufacturing; however, there is no way to guarantee the protection provided by the tubes that carry the stem cells in a 3D printer.
Although this technology has many benefits, you need a guide on how to check your operating systems. The challenge is time: we have very little time to achieve the necessary regulatory framework, process adaptations and quality models to make the paradigm shift at an industrial level that will allow the adoption of these technologies without risking people’s lives.
Today, there is not much investment in this area because those technologies are just starting to be implemented in Mexico. The regulatory gap will need to be filled as the demand for these technologies grows. However, I believe manufacturers and providers will start worrying about this issue soon. The global trend in healthcare is to create more personalized solutions, which represents a challenge for current regulation and pharmaceutical methods. We might find that regulations are almost dead on arrival because as they are released another technology is emerging. For this reason, the regulations must stay one step ahead so that they enter the system covering future risks. Academia, the authorities, the suppliers and the industry must be integrated into the regulatory process.
Q: What alliances does BPF, Part of QbD Group need to establish to fill these gaps?
A: We need to establish links with suppliers of these types of products and services. We are devoted to testing systems for managing anything that comes from a lab, for infrastructure projects, equipment or human resources. Never before have computational technologies been so intrinsically related to healthcare. We are starting to interact with high-end providers in Europe so that when they access the Mexican system we are ready to serve them. We also have an editorial program to cover those new subjects. Our team is working on the development of publications that could help us acquire the appropriate knowledge for when these technologies reach Mexico.
Q: How aware are Mexican companies about the importance of system-quality validations?
A: During the last presidential administration, COFEPRIS has been innovative and proactive in creating a new way of thinking about the Mexican market. COFEPRIS has also endeavored to make the new regulations public and to provide related training. Constant changes and the situation related to NAFTA may have distracted some companies from regulatory compliance, but they are aware of the problem. We are waiting for NOM-241 for medical devices that will likely introduce substantial changes to raise the level of compliance.
Q: What differentiates the company when it executes a project?
A: Our main differentiator is that we try to finish each project in the shortest possible time since the faster we finish a service, the more opportunities we have to help other clients. We work under a Project Management Institute (PMI) method and throughout each project we employ different controls, an initial document, weekly reports and frequent communication with the client. At the beginning of a project, we provide clients with a questionnaire to identify their needs, because in many cases they do not accurately know what they want or even what they need. Project management allows us to have better control of the project and its deliverables than most of the competition.
We have a strong financial structure and a robust quality system that is frequently audited. We have the reference and recommendation of our clients and this has led us to work with some of the most important companies in the healthcare sector in Mexico.