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Critical Thinking, New Technologies are Essential for Healthcare

Jaime Castro - QbD México (BPF, part of QbD)
Director General

STORY INLINE POST

Sofía Garduño By Sofía Garduño | Journalist & Industry Analyst - Tue, 10/25/2022 - 12:03

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Q: How does the firm help its clients adapt to the continuous innovations within the pharmaceutical industry?

A: Our company is a totally innovative organization. We are the only company of our kind of services in Mexico to invest in R&D and to have the ISO 9000 certification. This is a great differentiator that forces us to constantly measure the quality of our services while investing in continuous improvement. As part of our R&D strategy, we are always on the lookout for new solutions to address problems that arise.

Our company has also promoted the creation of the Mexican chapter of the International Society for Pharmaceutical Engineering (ISPE), which is a global reference for the creation and dissemination of health science information. ISPE has consolidated and grown in the country and this speaks of innovation because we are always committed to new adventures and undertakings.

We are creating the first school of critical thinking focused on regulatory compliance for the health industry, which will be launched in a few months. This school will develop critical thinking in the industry to promote the total change of the culture surrounding quality and processes. Critical thinking allows for better decision-making and better results. This initiative, and the promotion in to the regulation, will improve the quality of the products manufactured in Mexico.

Q: In what trends of the pharmaceutical industry is Mexico falling behind?

A: The main factor in which Mexico is falling behind is regulation. Unfortunately, regulation advances at a much slower pace than technology. We are experts in the validation of computerized systems, which is an area of ​​good practices focused on compliance of automatized processes. Within this branch, we know that computer systems advance quickly. We have technologies that we would not have imagined five years ago but at the regulatory level, these technologies have not been discussed. This delay causes a significant difference between what the standards ask for and what the new technologies can offer.

These technologies have many particulars that are not fully addressed by the standards of good practices in Mexico. For example, the standards for big data do not contemplate nanorobotic technologies, 3D printing, AI and VR, even though many of these technologies are being used in healthcare. Good practice regulations are meant to prevent any impact on the patient's health but since it takes a long time to update regulations, the regulatory expectations for these new technologies are not being fully covered. This is the main challenge not only for Mexico but also for the world. Regulation must advance at a higher speed to keep up with the new technologies that are emerging.

Q: What obstacles in the Mexican regulatory framework stop foreign players from operating in the country?

A: The regulatory framework is an obstacle because of the bureaucracy caused by regulatory updates. The COVID-19 pandemic also slowed down regulatory progress. ISPE issued two GAMP guidelines in recent years which will push for regulatory advancement. The consultation and evaluation period for the new standards of good practices is about to start, which is expected to bring progress.

Q: What does Mexico need to become a hub of clinical trials and be at the forefront of the pharmaceutical sector?

A: It is necessary to further strengthen regulatory standards to strengthen the protection of data, patients and companies that carry out clinical studies. It is also necessary to improve the computer systems that record and interpret this data. Many companies, both national and international, see Mexico as a relevant market for clinical studies due to the genetic characteristics of its population, which make the country an ideal location to perform studies that would impact the rest of Latin America. Drug manufacturers know that they have to study the Mexican genome to address the large number of diseases of genetic origin in the country. Mexico has a golden opportunity but seizing it will depend on the regulatory framework, which must be made more robust and agile to facilitate the establishment of these companies.

Q: How do you help companies adopt a culture of quality in post-pandemic times?

A: At QbD Mexico, we have built a team that offers high-quality services, which our clients have recognized. Our clients are under a great deal of stress because they have limited time to deal with regulatory compliance. For this reason, we select personnel with deep technical knowledge and the ability to deal with multiple ups and downs. We are at the center of our client’s regulatory compliance processes.

We do not provide a service as an activity but as a project. Our staff has training in project management, which has allowed us to obtain the recognition of our clients. We collected 290 client satisfaction surveys from about 350 services we have provided and no client has reported being dissatisfied. During our first five years, quality surveys found a level of satisfaction of 95 percent and last year, this rate climbed to 96 percent.

Q: What advances has the company made in the cannabis sector?

A: Cannabis has brought many benefits to humanity throughout history but it has been demonized as a result of having been abused. This trend is changing and industries that are proposing new uses for the cannabis plant and its derivatives are growing. But regulations for its use are advancing slowly. There is a large number of people who, due to an ailment, require this plant to improve their quality of life. If the country does not adopt a more agile regulation, it will end up affecting them. With a strong regulatory framework, more companies will surely emerge in Mexico.

Q: What are QbD’s main priorities for 2023?

A: Our priority is to continue positioning ourselves in the national market. We are the best positioned company in Mexico for the services we provide but the market is extensive. We strengthened our presence in the medical devices sector this year and we are preparing to better position ourselves in the cannabis, biological and biotechnological sectors. We are also well positioned in the logistics and distribution of medicines, biological and biotechnological products in Mexico. We even want to enter the food and cosmetics industries.

We are investing in training our staff. In Mexico, many activities covered by the regulatory framework require alliances with both companies and independent consultants. These alliances allow us to face the most diverse scenarios.

Last but not least, we aim to keep our company in the mind of our customers as the best solution for the regulatory compliance in validation, qualification and quality management system with our differentiators of flexibility, knowledge, service attitude and demonstrable quality results recommended by our customers.

 

QbD México (BPF, part of QbD) is a Mexican consultancy that focuses on validation, good manufacturing practices and quality management services for the pharmaceutical and healthcare industry. The company works with both local and international players coming to Mexico.

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