One of the biggest challenges for companies that manufacture or import/distribute health products is understanding and/or interpreting regulatory requirements, whether they are resolutions/legislation or international standards of the Health Surveillance Agency.
The applicability of certain requirements in certain segments must be carefully assessed by both companies and authorities, which makes the inspection process by health authorities or independent auditors a sometimes complex process.
The experience acquired over the years, having participated in more than 20 health surveillance inspections, both in Brazil and abroad for the purposes of certification of Good Manufacturing Practices by ANVISA, and many other audits (more than 30), by notified bodies for the purposes of ISO 13485 certification and CE marking, we can be certain of the main points that cause a lot of controversy and difficulties, both for inspectors and companies.
Difficulty in understanding or even misinterpreting a requirement can seriously compromise the company, whether due to difficulties in implementation or difficulties in presenting evidence. Furthermore, speaking on the part of inspectors, a mistaken interpretation of some requirement can lead to situations in which a company is harmed in a certain situation that it should not comply with.
In any case, the best way to clarify and clarify information is by exchanging experiences. There are doubts on all sides and the more we talk, converse and get closer, both with companies and with authorities, the only thing we can gain.
Training courses for companies and inspectors raise the level of inspections, since if the company is sure about the requirements of a certain legislation that must be met, and on the other hand, if inspectors are sure about the applicability of each requirement, the inspection becomes a common process, without major challenges, with each party doing “their part”.
In the end, what we have is the government acting as it should, that is, exercising inspection and approval of companies, in order to provide security to the population, and on the other hand, companies that can offer their products in full compliance with current legislation.
QR Group shares its knowledge with the public agency
In the last few days, we had the honor of giving a training course to the team of inspectors from the Health Surveillance Agency of Nova Lima, a city in the state of Minas Gerais, where we exchanged experiences and discussed several aspects common to inspections in general.
Below is a testimony from the unit manager, Julia.
“The training given by the professional Ana Paula, on 09/26/2024, contributed to the qualification of the management of VISA’s actions, broadening the reflections on practices and the vision of processes. The content presented was easy to understand and assimilate, allowing interaction between the speaker and the inspectors present who were able to clarify doubts and share experiences in the inspections of manufacturers/distributors/importers of health products.
The topics related to the control of projects, processes and productions were presented in a practical and applicable manner, demystifying the complexity of the topics and providing more security to the inspectors to carry out their activities.”
VISA Nova Lima Team
QR Group is ready to train your employees in interpreting the requirements of international legislation and standards for various processes, including those required to pass a health surveillance inspection. We have extensive experience in quality assurance, regulatory matters, risk analysis, and corrective and preventive actions. We also provide training courses for internal auditors and perform internal audits in companies that wish to outsource this activity.
Count on QR Group to elevate your team.
