Tag: Risk management in GMP

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

How ANVISA GMP Standards Influence the Development of New Pharmaceuticals

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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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GMP in Latin America (ANVISA, COFEPRIS)

How WHO GMP Helps Prevent Contamination in Pharmaceutical Manufacturing

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How WHO GMP Helps Prevent Contamination in Pharmaceutical Manufacturing Preventing Contamination in Pharmaceutical Manufacturing with WHO GMP Guidelines Introduction to Contamination Prevention in Pharmaceuticals Contamination in pharmaceutical manufacturing poses significant risks to patient safety and product efficacy, potentially leading to adverse effects, recalls, and reputational damage. The World Health Organization (WHO)’s Good Manufacturing Practices (GMP))…

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WHO GMP Guidelines

The Role of EMA GMP in the Manufacture of Controlled Substances

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The Role of EMA GMP in the Manufacture of Controlled Substances Ensuring Compliance in the Manufacture of Controlled Substances with EMA GMP Standards Introduction to EMA GMP Standards and Controlled Substances The manufacture of controlled substances is one of the most regulated areas in the pharmaceutical industry due to their potential for abuse, addiction, and…

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EMA GMP Guidelines

The Role of CAPA in TGA GMP Compliance in Pharmaceutical Facilities

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The Role of CAPA in TGA GMP Compliance in Pharmaceutical Facilities The Importance of CAPA in Ensuring TGA GMP Compliance in Pharmaceutical Facilities Introduction to CAPA in TGA GMP Compliance Corrective and Preventive Actions (CAPA) are a critical component of Good Manufacturing Practices (GMP) compliance, helping pharmaceutical facilities address deviations and prevent their recurrence. Under…

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TGA GMP Guidelines