The results of the MDSAP audits can be used for Anvisa’s regulatory decisions, such as Good Manufacturing Practices (GMP) certification, even during the pilot phase of the program.
The results of the program were used by Anvisa and other participating health authorities even during the pilot phase. The pilot phase, was carried out in the period from January 2014 to December 2016, corresponds to the implementation phase of the MDSAP program.
In 2017, the operational phase of the program began. At Anvisa, the audit reports issued by a given Audit Body may be used to support regulatory decisions, such as the issuance of CBPF, as of the publication of the RE recognizing the Audit Body, as established by RE No. 2.347/2015.
Inspection to Anvisa
At Anvisa, the audit reports issued by a given Audit Body may be used to support regulatory decisions, such as the issuance of BGMP also referred to as CBPF, as of the publication of the RE recognizing the Audit Body, as established by RE No. 2,347/2015.
Favorable audits are exempt from the inspection to be performed by Anvisa whenever the report meets the requirements of the MDSAP procedures such as:
- MDSAP audit template
- Auditor training requirements,
- MDSAP report preparation procedure
Brazilian GMP Application x MDSAP
Do we need BGMP if we already have MDSAP?
- The procedures to request BGMP from Anvisa have not changed due to the MDSAP.
- The subject of the certification petition remains the same.
Analysis of certification requests:
- Anvisa verifies whether the manufacturer to be certified has joined the MDSAP Program.
- The MDSAP audit report will be used as a subsidy for analyzing the certification process, in which case the inspection to be conducted by Anvisa may be waived.
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GRP Brazil Office provides Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical, medical device, and life-consumers companies worldwide to register them product with ANVISA the local Health Authority (HA).
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, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.