Tag: Risk management in GMP

How PMDA GMP Affects the Pharmaceutical Supply Chain in Japan

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How PMDA GMP Affects the Pharmaceutical Supply Chain in Japan How PMDA GMP Affects the Pharmaceutical Supply Chain in Japan Introduction to PMDA GMP and Its Impact on the Pharmaceutical Supply Chain The Pharmaceutical and Medical Devices Agency (PMDA) enforces Good Manufacturing Practices (GMP) guidelines in Japan, ensuring that pharmaceutical products are consistently produced and…

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PMDA GMP Guidelines

How to Train Your Team to Meet EMA GMP Standards

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How to Train Your Team to Meet EMA GMP Standards Effective Strategies for Training Your Team to Meet EMA GMP Standards Introduction to EMA GMP Standards Training The European Medicines Agency (EMA)’s Good Manufacturing Practices (GMP)) are critical for ensuring the safety, quality, and efficacy of pharmaceutical products. For pharmaceutical companies, achieving and maintaining compliance…

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EMA GMP Guidelines

The Importance of Documentation in NMPA GMP Compliance

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The Importance of Documentation in NMPA GMP Compliance The Importance of Documentation in NMPA GMP Compliance Introduction to NMPA GMP Documentation Requirements The National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), plays a critical role in ensuring the safety, efficacy, and quality of pharmaceutical products in China. One of the…

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NMPA GMP Guidelines

COFEPRIS GMP Standards and the Manufacture of Biologics in Mexico

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COFEPRIS GMP Standards and the Manufacture of Biologics in Mexico COFEPRIS GMP Standards and the Manufacture of Biologics in Mexico Introduction to COFEPRIS and GMP Regulations in Mexico In Mexico, the pharmaceutical industry is regulated by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), which ensures that all pharmaceutical products meet the highest…

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GMP in Latin America (ANVISA, COFEPRIS)

Key Changes in Schedule M (Revised) GMP: What You Need to Know

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Key Changes in Schedule M (Revised) GMP: What You Need to Know Understanding the Key Changes in Schedule M (Revised) GMP Guidelines Introduction to Schedule M (Revised) India’s pharmaceutical sector is one of the largest globally, and its reputation depends heavily on adherence to stringent regulatory standards. The Schedule M (Revised) guidelines under the Drugs…

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SCHEDULE - M - Revised

TGA GMP Compliance for Small and Medium Pharma Companies in Australia

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TGA GMP Compliance for Small and Medium Pharma Companies in Australia Achieving TGA GMP Compliance for Small and Medium Pharmaceutical Companies in Australia Introduction to TGA GMP Compliance The Therapeutic Goods Administration (TGA) enforces Good Manufacturing Practice (GMP) standards to ensure the quality, safety, and efficacy of pharmaceutical products in Australia. For small and medium-sized…

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TGA GMP Guidelines

MHRA GMP Compliance for Small and Medium Pharmaceutical Companies

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MHRA GMP Compliance for Small and Medium Pharmaceutical Companies Achieving MHRA GMP Compliance for Small and Medium Pharmaceutical Companies Introduction to MHRA GMP Compliance For small and medium-sized pharmaceutical companies (SMEs), achieving and maintaining compliance with the Medicines and Healthcare products Regulatory Agency (MHRA) Good Manufacturing Practices (GMP) can be a daunting task. MHRA GMP…

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MHRA GMP Guidelines

How to Achieve WHO GMP Certification in Pharmaceutical Manufacturing

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How to Achieve WHO GMP Certification in Pharmaceutical Manufacturing A Step-by-Step Guide to Achieving WHO GMP Certification in Pharmaceutical Manufacturing Introduction to WHO GMP Certification The World Health Organization (WHO)’s Good Manufacturing Practices (GMP)) certification is a globally recognized standard that demonstrates a pharmaceutical manufacturer’s commitment to producing high-quality, safe, and effective medicines. Achieving WHO…

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WHO GMP Guidelines

PMDA GMP Guidelines for Biologics: Key Compliance Requirements

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PMDA GMP Guidelines for Biologics: Key Compliance Requirements PMDA GMP Guidelines for Biologics: Key Compliance Requirements Introduction to PMDA GMP Guidelines for Biologics Biologics, including vaccines, monoclonal antibodies, gene therapies, and recombinant proteins, are complex pharmaceutical products derived from living organisms. Due to the intricate nature of biologic manufacturing, ensuring the safety, efficacy, and quality…

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PMDA GMP Guidelines

The Impact of EMA GMP Standards on the Pharmaceutical Supply Chain

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The Impact of EMA GMP Standards on the Pharmaceutical Supply Chain How EMA GMP Standards Shape the Pharmaceutical Supply Chain Introduction to EMA GMP Standards and the Supply Chain The pharmaceutical supply chain is a complex network of processes involving the sourcing, production, storage, and distribution of medicinal products. The European Medicines Agency (EMA)’s Good…

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EMA GMP Guidelines