Tag: Health Canada GMP regulations

How to Conduct a Self-Audit for EMA GMP Compliance

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How to Conduct a Self-Audit for EMA GMP Compliance Comprehensive Guide to Conducting a Self-Audit for EMA GMP Compliance Introduction to EMA GMP Self-Audits Ensuring compliance with the European Medicines Agency (EMA)’s Good Manufacturing Practices (GMP)) is a critical responsibility for pharmaceutical manufacturers. A self-audit, also known as an internal audit, is an essential tool…

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EMA GMP Guidelines

How ANVISA GMP Guidelines Support Sustainable Pharma Manufacturing

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How ANVISA GMP Guidelines Support Sustainable Pharma Manufacturing How ANVISA GMP Guidelines Support Sustainable Pharma Manufacturing Introduction to ANVISA GMP and Sustainability in Pharma The National Health Surveillance Agency (ANVISA) in Brazil plays a crucial role in ensuring that pharmaceutical products are safe, effective, and manufactured under controlled, high-quality conditions. Through its Good Manufacturing Practices…

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GMP in Latin America (ANVISA, COFEPRIS)

The Importance of WHO GMP in Clinical Trials and IMPs

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The Importance of WHO GMP in Clinical Trials and IMPs Understanding the Role of WHO GMP in Clinical Trials and Investigational Medicinal Products (IMPs) Introduction to WHO GMP in Clinical Trials Clinical trials are critical for evaluating the safety, efficacy, and quality of new drugs before they are approved for widespread use. At the heart…

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WHO GMP Guidelines

TGA GMP and Its Role in Ensuring Patient Safety in Australia

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TGA GMP and Its Role in Ensuring Patient Safety in Australia How TGA GMP Regulations Safeguard Patient Safety in Australia Introduction to TGA GMP and Patient Safety Patient safety is the cornerstone of pharmaceutical regulation, and the Therapeutic Goods Administration (TGA) plays a vital role in ensuring that medications available in Australia meet the highest…

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TGA GMP Guidelines

How Schedule M (Revised) Guidelines Address Contamination Risks in Pharma Manufacturing

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How Schedule M (Revised) Guidelines Address Contamination Risks in Pharma Manufacturing Addressing Contamination Risks in Pharma Manufacturing with Schedule M (Revised) Guidelines Introduction to Contamination Risks in Pharmaceutical Manufacturing Pharmaceutical manufacturing demands the highest levels of cleanliness and control to ensure product safety and efficacy. Contamination, whether microbial, chemical, or cross-contamination, poses a significant risk…

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SCHEDULE - M - Revised

The Role of CAPA in PMDA GMP Compliance

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The Role of CAPA in PMDA GMP Compliance The Role of CAPA in PMDA GMP Compliance Introduction to CAPA and PMDA GMP Compliance In the pharmaceutical industry, ensuring compliance with Good Manufacturing Practices (GMP) is essential for maintaining the safety, efficacy, and quality of drug products. The Pharmaceutical and Medical Devices Agency (PMDA) enforces GMP…

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PMDA GMP Guidelines

The Role of CAPA in NMPA GMP Compliance

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The Role of CAPA in NMPA GMP Compliance The Role of CAPA in NMPA GMP Compliance Introduction to CAPA and NMPA GMP In the pharmaceutical industry, maintaining the quality, safety, and efficacy of drugs is a top priority. The National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), enforces Good Manufacturing…

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NMPA GMP Guidelines

The Role of EMA GMP in Managing Risks in Drug Manufacturing

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The Role of EMA GMP in Managing Risks in Drug Manufacturing How EMA GMP Standards Facilitate Risk Management in Pharmaceutical Manufacturing Introduction to Risk Management and EMA GMP Standards Risk management is a cornerstone of pharmaceutical manufacturing, ensuring that processes, products, and facilities meet stringent quality, safety, and regulatory standards. The European Medicines Agency (EMA)’s…

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EMA GMP Guidelines

How to Improve Operational Efficiency with COFEPRIS GMP Compliance

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How to Improve Operational Efficiency with COFEPRIS GMP Compliance How to Improve Operational Efficiency with COFEPRIS GMP Compliance Introduction to COFEPRIS GMP and Operational Efficiency The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) is the regulatory body responsible for overseeing the pharmaceutical industry in Mexico. One of the key frameworks COFEPRIS enforces is…

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GMP in Latin America (ANVISA, COFEPRIS)