BGPM Certification
BGMP (Brazilian Good Manufacturing Practices) is a set of mandatory procedures created by Anvisa to ensure minimum quality standards in the manufacturing, storage, transportation, and distribution processes of health products. The main objective is to ensure that all products are safe, effective, and of high quality.
BGMP apply to all companies that manufacture medical devices, located either on national territory or abroad. Manufacturers of Class III and IV medical devices must be certified in compliance with BGMP requirements before they can register their products in Brazil.
BGMP Certification can be obtained through:
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Anvisa’s on-site audit
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Review of the QMS documentation
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Analysis of the MDSAP (Medical Device Single Audit Program) audit report
The BGMP certificate is valid for 2 to 4 years, depending on the route. After the first years of GMP Certification, the manufacturer should provide a self-inspection report. After an assessment based on documental analysis (audit report within the scope of ISO 13485 or MDSAP), ANVISA usually renews the GMP certification without the need of a re-inspection.
Adherence to GMP
We can help manufacturers adhere to the Brazilian Good Manufacturing Practices through our consulting services.
Evaluation of the QMS
Our Quality Assurance experts will analyze your company’s QMS documentation to ensure compliance with Anvisa’s requirements, according to ISO 13485 and RDC 665.
Mock Inspection
We can perform a remote or on-site “mock inspection” (pre-audit), which is recommended for proper gap analysis and to ensure the manufacturer complies with BGMP requirements – so you have time to correct any points before the actual Anvisa inspection.
Inspection Report
We will issue an audit report outlining any nonconformities found and suggest corrective and preventive actions (CAPA) to avoid potential audit findings and penalties.
Accompany the Inspection
Our team of experts and trained auditors are available to accompany the Anvisa inspection and help bridge the language barrier to overcome any misunderstandings.
File BGMP Petition to Anvisa
We will fill out all necessary forms, gather the proper documents, adjust them to fit the required norms, and submit the file for Anvisa’s approval.
...and much more!
Get in touch
Send us a message, we will be glad to help you through the pathway into the Brazilian market.
+55 (51) 3937-8726