GMP in Latin America (ANVISA, COFEPRIS)

How to Leverage ANVISA GMP for Regulatory Approvals in Brazil How to Leverage ANVISA GMP for Regulatory Approvals in Brazil Introduction to ANVISA GMP and Regulatory Approvals The National Health Surveillance Agency (ANVISA) is Brazil’s regulatory authority responsible for overseeing the safety, efficacy, and quality of pharmaceutical products. ANVISA plays a crucial role in ensuring…

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The Role of CAPA in Addressing GMP Violations Identified by ANVISA The Role of CAPA in Addressing GMP Violations Identified by ANVISA Introduction to CAPA and ANVISA GMP Violations The National Health Surveillance Agency (ANVISA) is responsible for regulating pharmaceutical products and ensuring that they meet the highest safety, efficacy, and quality standards in Brazil….

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How COFEPRIS GMP Compliance Affects Pharmaceutical Product Development How COFEPRIS GMP Compliance Affects Pharmaceutical Product Development Introduction to COFEPRIS GMP and Pharmaceutical Development The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) is the regulatory authority responsible for overseeing the safety, quality, and efficacy of pharmaceutical products in Mexico. As part of its mandate,…

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Common ANVISA GMP Violations and How to Address Them Common ANVISA GMP Violations and How to Address Them Introduction to ANVISA GMP Violations The National Health Surveillance Agency (ANVISA) is the regulatory body responsible for ensuring the safety, quality, and efficacy of pharmaceutical products in Brazil. One of the primary ways ANVISA enforces its regulatory…

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How ANVISA GMP Helps with Drug Stability and Expiry Dates How ANVISA GMP Helps with Drug Stability and Expiry Dates Introduction to ANVISA GMP and Drug Stability The National Health Surveillance Agency (ANVISA) is Brazil’s regulatory body responsible for overseeing the safety, quality, and efficacy of pharmaceutical products. One of the key frameworks enforced by…

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The Impact of ANVISA GMP on the Brazilian Pharmaceutical Market The Impact of ANVISA GMP on the Brazilian Pharmaceutical Market Introduction to ANVISA and the Role of GMP in Brazil The National Health Surveillance Agency (ANVISA) is Brazil’s regulatory body responsible for ensuring the safety, quality, and efficacy of pharmaceutical products, including drugs, medical devices,…

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How COFEPRIS GMP Guidelines Address the Issue of Counterfeit Drugs in Mexico How COFEPRIS GMP Guidelines Address the Issue of Counterfeit Drugs in Mexico Introduction to COFEPRIS and the Counterfeit Drug Problem The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) is the regulatory body responsible for ensuring the safety, quality, and efficacy of…

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How ANVISA GMP Standards Influence the Development of New Pharmaceuticals How ANVISA GMP Standards Influence the Development of New Pharmaceuticals Introduction to ANVISA GMP and Pharmaceutical Development The National Health Surveillance Agency (ANVISA) in Brazil is responsible for regulating the pharmaceutical industry, ensuring that drugs meet strict standards for safety, quality, and efficacy. Among the…

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How to Prepare for GMP Inspections by ANVISA and COFEPRIS How to Prepare for GMP Inspections by ANVISA and COFEPRIS Introduction to GMP Inspections by ANVISA and COFEPRIS Good Manufacturing Practices (GMP) inspections are a critical part of ensuring that pharmaceutical manufacturers comply with regulatory standards and maintain the highest levels of product safety, efficacy,…

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How COFEPRIS GMP Regulations Ensure the Safety of Pharmaceuticals in Mexico How COFEPRIS GMP Regulations Ensure the Safety of Pharmaceuticals in Mexico Introduction to COFEPRIS and GMP Regulations In Mexico, the pharmaceutical industry is governed by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), the regulatory body responsible for overseeing the safety, efficacy,…

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