Good Manufacturing Practice (GMP)
Health product companies and manufacturers wishing to market their products in Brazil must comply with the Brazilian GMP/ANVISA regulation standards. Since 2009, Anvisa made GMP/Anvisa mandatory to all risk class III and IV health product manufacturers.
Anvisa audits national and international health product manufacturers, including domestic importers. After the successful audit, Anvisa issues a GMP certificate, thus allowing the filing of product registration at Anvisa. The period to obtain such certificate depends on the demand of the Brazilian National Health Surveillance Agency itself
Manufacturers may also obtain the GMP certificate through the inspection report issued from an inspection performed by AO (Auditing Organizations) that are part of the MDSAP pilot project.
– The manufacturers should contract an AO to audit it within the MDSAP program. By hiring the organization for the MDSAP audit on the company intending to export products to Brazil, the audit should necessarily include the Brazilian regulatory requirements.
The MDSAP Pilot program has the following International Partners:
– ANVISA, the Brazilian National Health Surveillance Agency;
– the Australian Therapeutic Goods Administration (TGA);
– Health Canada, Canada;
– U.S. Food and Drug Administration, United States;
– Observers: Ministry of Health, Labor and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.
Oyster Consulting implements the Quality Management System/GMP for the following certifications: RDC-16/Anvisa; ISO 13485/2016; ISO 14371; CE marking; FDA and others.
The pilot project aims to enable health product manufacturers to hire an Auditing Organization, authorized under the pilot project, to perform a single audit encompassing the relevant requirements of the participating Regulatory Authorities;