Overview:

The Certificate of Good Manufacturing Practices is the document issued by Anvisa attesting that a certain establishment complies with Good Manufacturing Practices

The Certificate is issued per manufacturing unit, contemplating the production lines, pharmaceutical forms, special therapeutic classes and/or product risk classes for which the company was inspected.

 

What is a Certificate of Good Manufacturing Practice?

 The Certification in GMP –  is an assessment performed by qualified inspectors to ensure that a factory, any-where in the world, complies with the requirements determined by Brazilian legislation. 

Who must obtain a Certificate of GMP?

The Certificate of Good Manufacturing Practices is applied to companies that produce Drugs, Health Products, Cosmetics, Perfumes, Personal Care Products, Sanitizers and Pharmaceutical Supplies located in national territory, in Mercosur or other countries.

What is verified during the inspection?

The physical structures of the production areas, storage and Quality Control laboratories are evaluated, as well as all the documentation of the company’s Quality Assurance System.

WHAT HAPPENS WHEN THE COMPANY COMPLIES WITH THE GMP?

It means that the company has the capacity to produce the medicines with the desired quality and always with the same standard defined in the register in all the batches manufactured.

What happens after certification?

Certification is only part of the requirements for the registration of the drug, and the company must also prove the effectiveness of the drug and the desired quality standard to ensure effectiveness.

WHAT IS THE VALIDITY OF THE GMP CERTIFICATE?

The Good Manufacturing Practices Certificate will be valid for two years, counting from the date of its publication in the Official Gazette (DOU).

About Global Regulatory Partners

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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References:

Ministry of Health, Federal Government. Anvisa Section.

More Resources:

Brazil’s ANVISA

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