Brazil- Anvisa

Overview:

Anvisa instituted the Pilot Program to broaden the Quality of the National Health Products Industries, through Ordinance 680/2020. The objective is to strengthen the industries manufacturing health products of classes III and IV .

Pilot Program: 

The program will deal with health inspection from an educational bias. Through virtual meetings, the Agency inspectors will explain, for example, the technical criteria of Good Manufacturing Practices (GMP) and detail the list of documents to be verified during the inspection, in order to solve the doubts related to the Certification of Good Manufacturing Practices of Health Products.

In this way, the company itself will be able to make a self-assessment to verify if it meets the required requirements and, if so, promote the necessary adjustments before the sanitary inspection. With this, it is expected to optimize the inspection process under the responsibility of Anvisa, making it more effective and efficient, besides reducing the adoption of restrictive measures to the companies, expanding their knowledge about the regulatory administrative procedures.

During all stages of the pilot program, local Health Surveys will be invited to participate. The idea is to provide continuous training for professionals who act as inspectors.

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Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.  To learn more, please contact us at  info@globalregulatorypartners.com

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