Tag: Lean manufacturing and GMP

How to Achieve GMP Compliance in TGA Regulated Clinical Trials

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How to Achieve GMP Compliance in TGA Regulated Clinical Trials Ensuring GMP Compliance in TGA-Regulated Clinical Trials Introduction to GMP Compliance in Clinical Trials Clinical trials are critical for evaluating the safety and efficacy of new pharmaceutical products. The Therapeutic Goods Administration (TGA) in Australia enforces stringent Good Manufacturing Practices (GMP) to ensure the quality,…

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TGA GMP Guidelines

PMDA GMP Guidelines for the Manufacture of Injectable Drugs

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PMDA GMP Guidelines for the Manufacture of Injectable Drugs PMDA GMP Guidelines for the Manufacture of Injectable Drugs Introduction to PMDA GMP and Injectable Drugs Injectable drugs are among the most critical pharmaceutical products, as they are administered directly into the body, often for serious medical conditions. The safety and efficacy of injectable drugs depend…

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PMDA GMP Guidelines

How COFEPRIS GMP Guidelines Address the Issue of Counterfeit Drugs in Mexico

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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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GMP in Latin America (ANVISA, COFEPRIS)

How EMA GMP Standards Promote Sustainability in Pharmaceutical Manufacturing

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How EMA GMP Standards Promote Sustainability in Pharmaceutical Manufacturing Sustainability in Pharmaceutical Manufacturing with EMA GMP Standards Introduction to Sustainability and EMA GMP Standards Sustainability has become a critical consideration in pharmaceutical manufacturing as the industry seeks to reduce its environmental footprint while maintaining high standards of quality and safety. The European Medicines Agency (EMA)’s…

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EMA GMP Guidelines

How WHO GMP Guidelines Influence Drug Packaging and Labeling

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How WHO GMP Guidelines Influence Drug Packaging and Labeling Understanding the Impact of WHO GMP Guidelines on Drug Packaging and Labeling Introduction to Drug Packaging and Labeling under WHO GMP Drug packaging and labeling are critical components of pharmaceutical manufacturing, playing a vital role in ensuring product integrity, patient safety, and regulatory compliance. The World…

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WHO GMP Guidelines

Common Schedule M (Revised) GMP Violations and How to Avoid Them

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Common Schedule M (Revised) GMP Violations and How to Avoid Them Identifying and Avoiding Common Schedule M (Revised) GMP Violations Introduction to Schedule M (Revised) GMP Compliance Schedule M (Revised), under the Drugs and Cosmetics Act, 1940, sets forth stringent Good Manufacturing Practices (GMP) to ensure the safety, efficacy, and quality of pharmaceutical products. Compliance…

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SCHEDULE - M - Revised

The Impact of MHRA GMP on the Pharmaceutical Supply Chain

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The Impact of MHRA GMP on the Pharmaceutical Supply Chain Understanding the Impact of MHRA GMP on the Pharmaceutical Supply Chain Introduction to MHRA GMP in the Supply Chain The Medicines and Healthcare products Regulatory Agency (MHRA) enforces stringent Good Manufacturing Practices (GMP) to ensure the safety, quality, and efficacy of pharmaceutical products. While GMP…

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MHRA GMP Guidelines

How TGA GMP Guidelines Influence the Manufacture of Biologics and Biosimilars

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How TGA GMP Guidelines Influence the Manufacture of Biologics and Biosimilars The Role of TGA GMP Guidelines in Biologics and Biosimilars Manufacturing Introduction to Biologics, Biosimilars, and TGA GMP Guidelines Biologics and biosimilars represent a rapidly growing segment of the pharmaceutical industry due to their potential to treat complex and chronic conditions. These products, derived…

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TGA GMP Guidelines

How NMPA GMP Affects Drug Packaging and Labeling Compliance

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How NMPA GMP Affects Drug Packaging and Labeling Compliance How NMPA GMP Affects Drug Packaging and Labeling Compliance Introduction to NMPA GMP and Drug Packaging/Labeling In the pharmaceutical industry, packaging and labeling are crucial elements of product safety, efficacy, and traceability. In China, the National Medical Products Administration (NMPA) enforces Good Manufacturing Practices (GMP) guidelines…

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NMPA GMP Guidelines

How to Leverage PMDA GMP for Drug Safety and Quality Assurance

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How to Leverage PMDA GMP for Drug Safety and Quality Assurance How to Leverage PMDA GMP for Drug Safety and Quality Assurance Introduction to PMDA GMP and Its Importance in Drug Safety Good Manufacturing Practices (GMP) are fundamental in ensuring the safety, quality, and efficacy of pharmaceutical products. In Japan, the Pharmaceutical and Medical Devices…

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PMDA GMP Guidelines