Tag: Quality Management Systems (QMS) in pharma

How to Address Non-Conformities Identified by COFEPRIS During GMP Inspections

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How to Address Non-Conformities Identified by COFEPRIS During GMP Inspections How to Address Non-Conformities Identified by COFEPRIS During GMP Inspections Introduction to COFEPRIS and GMP Inspections The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) is Mexico’s regulatory authority responsible for overseeing the safety, efficacy, and quality of pharmaceutical products. One of COFEPRIS’s most…

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GMP in Latin America (ANVISA, COFEPRIS)

How WHO GMP Guidelines Ensure Consistency in Drug Manufacturing

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How WHO GMP Guidelines Ensure Consistency in Drug Manufacturing Ensuring Consistency in Pharmaceutical Manufacturing with WHO GMP Guidelines Introduction to Consistency in Drug Manufacturing Consistency in pharmaceutical manufacturing is critical to ensure that every batch of medicine meets the same high standards of quality, safety, and efficacy. The World Health Organization (WHO)’s Good Manufacturing Practices…

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WHO GMP Guidelines

How to Integrate NMPA GMP with Other International Regulatory Requirements

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How to Integrate NMPA GMP with Other International Regulatory Requirements How to Integrate NMPA GMP with Other International Regulatory Requirements Introduction to NMPA GMP and International Regulatory Alignment The global pharmaceutical industry operates in a highly regulated environment where adherence to Good Manufacturing Practices (GMP) is crucial for ensuring the safety, quality, and efficacy of…

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NMPA GMP Guidelines

PMDA GMP and the Role of Sustainable Manufacturing Practices

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PMDA GMP and the Role of Sustainable Manufacturing Practices PMDA GMP and the Role of Sustainable Manufacturing Practices Introduction to Sustainable Manufacturing Practices and PMDA GMP The pharmaceutical industry is at the forefront of the global push for sustainability. As the sector faces increasing pressure from regulators, consumers, and the public to reduce its environmental…

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PMDA GMP Guidelines

How to Integrate Digital Solutions for EMA GMP Compliance

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How to Integrate Digital Solutions for EMA GMP Compliance Leveraging Digital Solutions to Achieve EMA GMP Compliance Introduction to Digital Solutions in EMA GMP Compliance In the pharmaceutical industry, maintaining compliance with the European Medicines Agency (EMA)’s Good Manufacturing Practices (GMP)) is critical for ensuring product safety, quality, and efficacy. As regulatory requirements grow more…

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EMA GMP Guidelines

The Role of Data Integrity in MHRA GMP Compliance

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The Role of Data Integrity in MHRA GMP Compliance Ensuring Data Integrity for MHRA GMP Compliance Introduction to Data Integrity and MHRA GMP Data integrity is a fundamental aspect of Good Manufacturing Practices (GMP) compliance, ensuring that all data is accurate, consistent, and reliable. For pharmaceutical manufacturers, maintaining data integrity is critical for demonstrating product…

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MHRA GMP Guidelines

The Future of TGA GMP Guidelines and Their Impact on Australian Pharma

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The Future of TGA GMP Guidelines and Their Impact on Australian Pharma Exploring the Evolution of TGA GMP Guidelines and Their Role in Shaping Australia’s Pharmaceutical Industry Introduction to TGA GMP Guidelines The Therapeutic Goods Administration (TGA) enforces Good Manufacturing Practices (GMP) in Australia to ensure the safety, efficacy, and quality of pharmaceutical products. As…

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TGA GMP Guidelines

How WHO GMP Guidelines Support the Development of Biopharmaceuticals

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How WHO GMP Guidelines Support the Development of Biopharmaceuticals The Role of WHO GMP Guidelines in Biopharmaceutical Development Introduction to Biopharmaceuticals and WHO GMP Biopharmaceuticals, including vaccines, monoclonal antibodies, and cell and gene therapies, represent a rapidly growing segment of the pharmaceutical industry. These complex, biologically derived products offer innovative treatments for various diseases, but…

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WHO GMP Guidelines

How Schedule M (Revised) GMP Guidelines Ensure Safety in the Manufacturing of Injectable Products

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How Schedule M (Revised) GMP Guidelines Ensure Safety in the Manufacturing of Injectable Products Ensuring Safety in Injectable Manufacturing with Schedule M (Revised) GMP Guidelines Introduction to Injectable Manufacturing and GMP Injectable products are critical in healthcare, offering rapid and targeted delivery of medications directly into the bloodstream or tissues. However, the complexity of their…

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SCHEDULE - M - Revised

The Future of ANVISA GMP Regulations in Brazil’s Pharmaceutical Industry

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The Future of ANVISA GMP Regulations in Brazil’s Pharmaceutical Industry The Future of ANVISA GMP Regulations in Brazil’s Pharmaceutical Industry Introduction to ANVISA GMP and Its Role in Brazil’s Pharmaceutical Industry The National Health Surveillance Agency (ANVISA) is the regulatory authority responsible for overseeing the safety, efficacy, and quality of pharmaceutical products in Brazil. Through…

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GMP in Latin America (ANVISA, COFEPRIS)