The regulatory framework governing drug development is fluid. Technological innovation, the adoption of consumer-driven digital therapeutic interventions, and the shift to personalized medicine are some of the factors influencing new regulatory requirements and imposing stricter quality standards. So what are the biggest pain points in regulatory compliance for pharmaceutical manufacturers today, and how best to address them?
Procaps Director of Regulation, Sandra Mosquera, answers these pressing questions in the Q&A below.
Q.: What is shaping the global regulatory landscape for pharmaceutical and nutraceutical manufacturers today?
SM: That’s a good question. I believe there are three main factors that are shaping the regulatory landscape, or should be.
#1 Request for a more efficient approval process.
New drugs go through complex clinical and approval stages, which can take 12 years or more before they reach patients. To keep timelines as short as possible, drug developers are always involved with regulators early in the process, with open communication at all stages of development and submission to ensure expectations of all stakeholders are met. I have to keep the channel. There is also a need for better international cooperation and harmonization among regulatory authorities to reduce duplication of effort and facilitate global drug development and access. A balance must be struck between introducing more efficient approval processes and maintaining scientific rigor.
#2 advances in technology
Advances such as personalized medicine, real-world evidence (RWE) data, and most recently artificial intelligence (AI) and machine learning (ML) need to be considered and framed on the basis of specific regulatory scenarios. We sometimes think that science advances faster than regulation, but somehow it does, and efforts to keep up with innovation are difficult. After all, it’s a collaborative effort, and I think of it as akin to an ekiden. There are no individual winners, either we win together (innovation and regulation) or there is no victory.
#3 Keep a keen sense of patient-led
This is not a trend, but it should be and we at Procaps are very focused on it. This is what we call the basics. At Procaps, this has always been our motto. We provide innovative solutions to improve global health. Improved! sharp?Sharp calls to maintain commitment cIn a GMP environment (and that ‘c’ is important!), we have a ‘sharp eye’ that keeps us up-to-date with new regulations, being part of important bodies, participating in regulatory discussions, and rewarding our achievements. This is because it is required to have It gives clients confidence and ultimately improves patient and consumer well-being.
Q.: What are the main pain points facing pharmaceutical and nutraceutical manufacturers when it comes to quality assurance and compliance?
SM: cGMP is a way to establish a culture of quality that leads to continuous improvement. Although GMP requirements are well defined, non-compliance is still one of the causes of drug shortages in many countries. A major challenge is to “translate” the language of quality and compliance requirements across the organization in order to build a robust and effective quality culture across the enterprise. Better understanding leads to more sustainable implementation and compliance.
Another pain point in this industry is data management. There is still some room for improvement in terms of data generation methods and the availability of their use towards achieving more predictable quality and compliance systems.
Harmonizing requirements is also an important aspect. I know this is a path that the industry and regulators started some time ago and it is improving well, but there is still much work to be done.
Q.: How can manufacturers overcome these pain points?
SM: Effectively communicate the quality strategy within the organization to ensure that everyone has a clear quality mindset and compliance can engage each process towards the same goal. Building quality into products from design through the product lifecycle is one of the key aspects of overcoming the challenges that typically arise. The greater the investment in development and process migration, the greater the success in the commercial phase is guaranteed.
Effective data analytics to predict the behavior of products and processes enables manufacturers to be more efficient and at the same time continue to meet requirements.
Q.: How does Procaps address regulatory compliance and quality assurance challenges?
SM: Yes, it’s a challenge! I believe that regulatory compliance requires proactive action. Our Regulatory Intelligence Program provides a systematic approach to understanding all changes and new regulations that may affect our business, products and processes. Now comes the “exciting” part of determining what needs to be adjusted or improved. We strive to reflect regulatory changes and industry best practices. This is a never-ending process of learning and improvement and a critical task for pharmaceutical companies to effectively navigate the evolving regulatory environment.
From a quality assurance perspective, transformation to optimize and simplify processes to overcome any regulatory challenge is a key factor. Keeping staff thinking about how to implement efficient processes while meeting requirements is the best approach you can use to ensure patient needs are met.
Q.: What are best practice compliance controls for CDMOs?
SM: In answer, we share our successful experience.
#1 Stay up to date with the latest regulations, guidance and requirements. As mentioned earlier, having an active regulatory information team helps with this.
#2 Develop internal and external networks: Internally, don’t work in silos. Compliance, pharmacovigilance, and R&D all need to meet regularly and share knowledge. Externally, we participate in regulatory associations, participate in regulatory discussions, and secure consulting services as needed.
#3 Maintain a keen sense of patient initiative. I mentioned this earlier.
#Four Understanding Stakeholder Needs: This is not just about “making a list” of stakeholder needs and expectations, but how to meet those needs from a regulatory perspective.
#Five In our Regulatory Affairs department, we strive to make it easy to understand, as regulations can be difficult to ‘explain’. We must ensure that appropriate recommendations regarding regulatory expectations and the consequences of non-compliance with those regulations are well understood by all stakeholders.
question: How do you envision the future of manufacturer quality and compliance?
SM: In the near future, new technologies and data analytics will be central to quality assurance. AI and ML are already being used by leading CDMOs to anticipate process issues and focus resources on critical points to meet regulations to ensure consistent compliance. An automated device that can accelerate analysis or operate autonomously. Autonomous instruments are used for critical tasks such as sample preparation, dissolution method execution, automated gravimetric analysis, and in-line process analysis.
AI software is employed not only to reduce method development time, but also to develop new APIs and complement in-product development. For example, it helps predict API solubility, potential incompatibilities with some excipients, and potential incompatibilities. Impurities that may form within certain products. Real-time visibility into processes and their data accelerates the efficiency and productivity of your drug development framework.
Over the years, we have developed and implemented some of these emerging technologies in a process called R&D 4.0. The aim is to apply the technologies provided by Industry 4.0 to R&D activities to reduce time to market.
