Validation Services for the Pharma IndustryTue, 09/06/2016 - 17:09
Q: What are the main challenges surrounding validation practices in the pharmaceutical industry?
JC: Validation services are expensive and even more so if a company allocates a whole division to it. This is not only true due to human capital training but also to the number of devices and appliances needed in reading an analysis processes. As such, subcontracting validation services from companies like ValidPro is a better fit for most laboratories and companies. Our job consists of unveiling the company’s shortcomings, wrongdoings and areas of opportunity. As such, creating strong relationships and ties with our clients is crucial, especially as they will define the project’s success. Our first challenge is to be perceived as the entity that can help them solve their issues rather than be seen as the enemy. Secondly, we must push for total compliance with the country’s regulatory framework, which calls for added efforts, work and resources.
Q: What are the internal processes of validation? How do you differentiate yourselves?
FH: We have an internal system of quality control that assures the quality of our services in a constant and permanent manner. This system is updated on an ongoing basis. In the commercial area, we have created a new team that caters to clients and gives them the attention they need. This has led to a sales boost that caused exponential growth over the past three years.
JC: We launch products with alliances and this has brought great benefits to us. ValidPro is a company that has not been afraid to make alliances. We do not see competitors as opposition but as complementary. This has allowed us growth alongside other businesses.
Q: Who are ValidPro’s most relevant clients and what services do they ask of you?
FH: We work with top tier clients such as Boehringer Ingelheim, Laboratorios Valdecasas, Ulsatech, Merck Sharp & Dohme, Pisa and Praxair. The services they demand vary but we can provide a broad spectrum of services from the validation of entire manufacturing plants to equipment and area qualifications. ValidPro also usually validates computerized equipment. Our services cover the whole validation spectrum regardless of division or area. We must understand the industry undergoes systemic regulation restructuring, forcing companies to adapt to the changes. Therefore, there is always business to be secured and companies to be helped.
Q: Considering the importance of securing competent human capital, to what extent does ValidPro have special relationships with academic institutions?
JC: Even though we do not have specific alliances we have worked with academic institutions through courses and conferences. We do not see these conferences as a way to develop future ValidPro workers considering the validation field of study is new in schools and universities. The company normally retains the services of chemists, pharma-biological chemists, chemical engineers and pharmaceutical engineers due to their underlying understanding of the manufacturing process of medicaments. When someone does not fully understand what a particular validation field of work entails then they are called in for further training by ValidPro. The learning curve for a trainee to become an A-level engineer is somewhere between one and one and a half years.
Q: Where do you see Mexico’s legal framework evolving and what are the trends that will push for this transition?
JC: Trends will not only be defined by industrial technicalities but also by external factors like the country’s socioeconomic landscape and its politics. For instance, COFEPRIS is receiving the ISO 9001 certification changing its perspective as a sanitary regulator and consequently shifting the way companies work.
The NOM-059 will enter into force by mid-2016 and we must all fall in line with it. The industry will be under more scrutiny due to the country’s economic environment but its strength and importance on a global level will allow it to minimize adverse effects. The instability of the Mexican peso and other international currencies has impacted manufacturing activities and its industries. But the market continues to behave similarly to how it did in the past.