The research, development and production of biological products has grown dramatically in recent years, and Brazil has accompanied this growth. To ensure the safety of these products, we need to implement quality rules that are standardized worldwide and recognized by our Health Surveillance Agency (ANVISA), and by international regulatory bodies.
To ensure high quality research results, it is necessary to maintain the so-called GxP - Good X Practices, which are regulations and guidelines directed at companies with a biological focus, in the manufacture of products aimed at biotechnological research, medical products, medicines, food and medicine areas , ensuring that final products are safe for consumers.
GxP covers a wide variety of activities related to good practices, such as GLP (Good Laboratory Practices), GCP (Good Clinical Practices) and GMP (Good Manufacturing Practices), each with different and specific guidelines based on the research area that will be applied.
For implementation, the type of product manufactured must be taken into account and it is important to bear in mind that the guidelines of each country related to research and biotechnology are not static and undergo updates according to the evolution of studies and updates. of technologies.
And this November, the second Global Training Hub for Biomanufacturing (GTH-B) program of the World Health Organization (WHO) was held, the 2022 Introductory Training Course for Standard Practices (GxP), carried out by the International Vaccine Institute and Ministry of Health and Welfare. The course had a total of 272 trainees, receiving professional training on international quality standards for the development and manufacture of vaccines and biomedical products, as well as technical visits to GC Pharma and Sartorius.
Biotimize was present throughout the course held in Korea, being represented by Researcher jr. Bruna Campos, who was able to expand her knowledge in the area and bring even more wisdom to the company. Bruna describes the experience as incredible and tells us what it was like to be in this immersion of knowledge:
“For me, the whole experience was incredible, from the selection process to the friends I will take with me beyond training. I was very happy to have been selected, and to be able to represent Biotimize, taking our name to the world. This was a great opportunity to be able to show them that we are interested in learning what we need to know, and that we will soon be structuring a company that follows quality standards and offers security in the service provided.
We had professors who are a reference in their professional field, who approached the content in detail and knew how to make us understand every detail of the processes. The training was based on many group activities and simulations of applications of the tools used, facilitating the understanding of what our daily life would be like in practice.
In addition to the classes, the organization of the event was impeccable with an indescribable receptivity, leaving me wanting to return in the next opportunities.
I hope that with the knowledge I acquired and that I will continue to seek, I can bring to Biotimize and to our country, an environment for the production of biological products that is pleasant in the eyes of the regulatory bodies, and make the legislation not be seen by companies, as an animal seven-headed, as is commonly seen.”