Redator Kivalita em 1 de July de 2021 em Articles

Anvisa x Inmetro: what they require in industries

Whenever there is commercialization, implementation or manufacture of products and services to the Brazilian population, whether national or from abroad, it is necessary to guarantee the regulation and certification of good practices, which will ensure their origin and improvements in quality processes.

To inspect and ensure that product manufacturers and service providers follow their market offerings, in accordance with the standards established specifically for their industries, the performance of Anvisa and Inmetro in this regard are essential.

See who’s who in monitoring and process inspection

The National Health Surveillance Agency, called Anvisa, is linked to the Ministry of Health and exercises sanitary control of products and services to the sectors: medical, cosmetic, sanitize, health, among others. To this end, Anvisa establishes standards with good practices for each of the sectors it operates. 

From time to time, Anvisa promotes the revision and consolidation of such standards. Recently, on 5/31/21, Anvisa confirmed that it has completed the third stage of the review and consolidation work (based on Decree 10,139/2019), including the evaluation of 180 standards related to the agency’s macro-themes: pharmacopoeia, analytical laboratories, pharmaceutical inputs, internal management, organization and management of the National Health Surveillance System, blood, tissues, cells and organs, health services and health services.

This process improved the legislative technique and the wording, and dropped the number of standards to 131, as part of the strategy of simplification and rationalization of the regulatory stock of Anvisa.

Thus, with regard to companies, Anvisa has the role of monitoring and supervising their environments, processes, standardization of procedures, insums applied in manufacturing, as well as technologies inherent to the production of products or offers of health services. Due to the Covid-19 pandemic, most of these inspections are taking place remotely.

In the context of drug manufacturers, for example, the agency inspects and carries out the assessment of compliance with Good Manufacturing Practices (BPFs) of Active Pharmaceutical Inputs (IFAs). A survey by Anvisa revealed that 64% of the pharmaochemical industries are located in São Paulo, Rio de Janeiro and Goiania. More than identifying trends, agency inspections point to needs for improvement slates for businesses. 

The National Institute of Metrology, Quality and Technology, known as Inmetro,is also an executive agency, however, it is linked to the Ministry of Economy.

Inmetro supervises companies in order to increase their productivity, through mechanisms dedicated to improving the quality of products and services or even by encouraging national technological innovation.

Among some of Inmetro’s competencies are: implementing national metrology and conformity assessment policies (According to ABNT NBR ISO 17025); inspect technical and legal standards for units of measurement, methods and measuring instruments; implement, maintain and standardize the traceability chain of the standards of units of measures universally accepted and, in the productive sector, regarding the quality of goods and services; among others. Also for companies, Inmetro supports the use of technique focused on quality management and also performs the accreditation of laboratories that seek REBLAS certification.

Thus, like Anvisa, Inmetro is also committed to rationalize its regulatory stock, seeking to facilitate the path to companies that want to make their innovative products and services available in the market, stimulating competitiveness. On its website, for example, Inmetro states that its Compliance Assessment Board has already reduced its regulatory stock by 12% since September last year, from 486 to 430 regulatory acts. By the end of this year, the reduction is expected to represent 40%, reaching 292 acts.

Do your company’s processes comply with regulatory agency standards?

Logically, to be up to date with the validity and consolidation of all these standards of regulatory agencies, companies need competence and time – which is not always possible, due to the fact that the teams are immersed in their day-to-day operation, without space for the management of this theme or interaction with the latest updates from Anvisa and Inmetro.

Kivalita Consulting, which is a Brazilian startup specialized in the development of quality management and technology validation for companies in the area of Life Science, it can be the arm of companies that need to review manufacturing processes and improve them to avoid deviations, waste, rework and high costs, or even an action of Anvisa or Inmetro because their processes are not properly in accordance with the standards of commercialization, implementation and manufacture in force to the products and services in its sector.

Contact us and learn how Kivalita Consulting can help your company on this journey, ensuring quality management, so that all your manufacturing and marketing processes of products and services are properly certified!

Sources: and

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