How does it work ANVISA GMP Certification Process

To understand how GMP – Good Manufacturing Practices - Pre-Audit works, you can count on RAGB’s specialists’ team. As a Regulatory Affairs reference and providing regulatory services for companies located in more than 20 different countries, the specialists are trained and used to work with the standards for many kinds of products to be sold in Brazil according to the laws of public entities and agencies.

Now you will start to know about RAGB’s services, about how can RAGB’s office to help your business to see clearly how it works to get your factory ANVISA GMP Certified.

What are GMP – Good Manufacturing Practices ANVISA?

ANVISA is a Brazilian public agency that handles health issues (food and health related products, like food, food supplement, sanitizing products, hygiene products, cosmetics, medical devices, medical instruments, and health related software).

Good Manufacturing Practices are a set of standards to keep the products safe from having issues related to the quality and safety, such as contamination, adulteration, falsification, and other issues that may put the consumers health in any kind of risk.

 Good Manufacturing Practices have as a goal to save the users of health-related products and services from issues and troubles, and it works as a guide and companies must follow a set of standards that involve from having the responsibilities well defined in procedures to how the workers handle the products.

What companies must apply for GMP – Good Manufacturing Practices ANVISA Certification?

Good Manufacturing Practices have as a goal to save the users of health-related products and services from issues and troubles, and it works as a guide and companies must follow a set of standards that involve from having the responsibilities well defined in procedures to how the workers handle the products.

GMP Certification has to be taken by manufacturers of:

  • Medical devices, including software for health applications
  • Cosmetics
  • Parfums
  • Hygiene products
  • Sanitizing products
  • Food, food supplement and its ingredients

Basic Steps of GMP – Good Manufacturing Practices ANVISA Certification

First of all, it is very important to know that GMP Certification is taken by the factory located outside of Brazil (through a Brazilian importer company), or it must be taken from a Brazilian company that manufacturers the products in Brazil, because these are the two kind of companies that can be the responsible for product registration in Brazil (manufacturers or importers). In the first case, GMP Certification attaches the Brazilian company that will handle the product registration to the outsider factory. It means that if the factory changes its site, or if changes the owners (legal responsible person/directors), ANVISA has to be informed by submitting a documental process that shows and proves what has changed.

In case of a Brazilian manufacturer, it takes its own GMP Certification. For an importing company, it applies for GMP in manufacturing company’s behalf, because it is an ANVISA standard that GMP applications must be done by the company that will be able to be responsible for the product (s) in Brazil.

First step is uniting the documents that ANVISA requires. The regulatory affairs specialist person checks if it fits to ANVISA standards and informs the factory if any information or document is missing. Then, the documental process is sent to ANVISA. ANVISA’s technical person analyzes the documents (and they can also ask for any other documents of information, whenever they feel necessary). With the documental step won, the process come to the next level.

There is a deadline for companies to get ANVISA’s auditors visit, because even seeing the documents, they will come to the factory in person (or through a video audit if it is not possible to come for some reasons), to see the application of these documents during the factory’s routine. The audit may have 3 results: approved, approved with restrictions (points to change or amend) and not approved. A report will be issued by the auditors and sent to ANVISA to issue GMP Certificate.

Importer possible strategies

If your company is interested in bringing products to Brazil, you must have 3 options of strategies, regulatorily speaking:

  1. To open an importing company in Brazil
  2. To import through one of your costumers companies (if already licensed with ANVISA to import) – and in this case product registration will be in their hands
  3. To use a holder company (RAGB can be that company), so your company can be free to choose as many costumers as you want, and none of them will control your registers in Brazil or know about each other, we handle your registers and give some authorizations to the costumers you’ve selected to sell your products.

Click to read about item 3 (Hosting Services)

Why hiring a Regulatory Affairs Specialist company?

ANVISA’s standards can be different from any other part of the world sometimes. That is exactly what makes a Regulatory Affairs Specialist company so important: the experience. To be gone through the steps repetitively makes RAGB to anticipate potential issues regarding the documents that may represent some trouble during the GMP Certification process.

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