Continuous Improvement Based on International Standards

Q: How do the firm’s methodologies raise the quality of its pharmaceutical clients?

A:  Our methodology is similar to a project management approach, which means we must build a close relationship with our client. Most of our work focuses on implementing quality management systems and quality verification systems, all within the context of regulatory frameworks. After designing and implementing a solution, we hold weekly follow-up meetings to determine further improvements based on performance. The idea is that clients can see how they are progressing.

Our digital platform allows access to all official documents related to quality management. Other areas in which we have now built several years of experience are risk analysis and validation of computer systems. Most of our staff has been with us for a long time, which means we have a great deal of expertise. Many clients will ask for the same person at our company because they already have a working relationship with that person. The success of our services is best reflected in the positive evaluations we receive and the recommendations we get from one client to another.

Q: What has been the impact of companies taking up European standards in Mexico?

A: Even though we are a Mexican company, we are part of an international group. The QBD group has its main headquarters in Belgium. This structure has granted us access to the European pharmaceutical sector and provided us a greater understanding of how regulations work there. Generally speaking, when a European client comes to Mexico, we can find a proposal that combines European and Mexican regulations. This is not particularly hard, as Mexican regulations generally follow high standards. An area where we see greater discrepancy is in internal corporate management. There are many bad practices in Mexico that European companies have to tackle with specific structures in financial, administrative and personnel management. We are working with many clients on how to implement together the new NOM-035 related to social risks in the workplace.

Q: What is your relationship with the International Society for Pharmaceutical Engineering (ISPE)?

A: Our company staff is affiliated with ISPE. However, about a year and a half ago, a group of people in the industry, myself included, decided to work together and create a local ISPE chapter here in Mexico. Given that the pharmaceutical industry in Mexico has a global impact, we felt there was a need for it. There were four attempts in the past to launch it but recently we received the official certificate of ISPE’s Mexico chapter in Las Vegas. Having a local chapter will allow us to improve the technical standards of the industry and create greater industry collaboration. The official launch in Mexico will be in March 2020 and we are looking for professionals who want to affiliate.

The chapter runs on a nonprofit scheme and will raise funds through events. Once we grow, we will improve our position within the international organization and potentially gain funding from them. ISPE’s industry standards certainly serve as a reference, not only covering pharmaceutical topics but also other areas such as hospitals, doctors, biotechnology and warehouse logistics. Several of our own norms in Mexico were inspired by these guides.

Q: What is your opinion on the potential legalization of cannabis?

A: I believe it is a positive development. There are still many myths and prejudices about cannabis, which should be confronted by the scientific community. Multiple studies have demonstrated a beneficial impact from treatments with cannabis. Of course, the way it is used and in what form matters. I think the way laws are created can have a big impact on how this will play out. We do not want to empower bad people to do bad things. To prevent this, I believe policymakers should get together with scientific experts and private sector players to discuss responsible regulations. There are many interested parties and our Belgian and Colombian colleagues have been working with other private parties to explore this topic. 

Q: What are your short-term objectives?

A: We want to strengthen our participation in the medical devices sector, as well as biotechnology, and potentially cannabis. In the long term, we would like to grow our participation in services at an international level. This year, we developed a unit that is fully dedicated to services at an international level for global clients of the QBD group. This should further open the door for foreign companies to come to Mexico. To reach out to clients, we will continue to participate in important industry events and to collaborate with publications.

BPF, part of QBD, is a Mexican consultancy that focuses on providing solutions for good practices and quality management among clients in the pharmaceutical industry. The company works with both local and international players coming to Mexico