Tag: GMP certification

How WHO GMP Guidelines Support the Manufacture of Orphan Drugs

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How WHO GMP Guidelines Support the Manufacture of Orphan Drugs The Role of WHO GMP Guidelines in Manufacturing Orphan Drugs Introduction to Orphan Drugs and WHO GMP Orphan drugs are pharmaceutical products developed to treat rare diseases affecting a small percentage of the population. These conditions, often termed “orphan diseases,” are underserved due to limited…

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WHO GMP Guidelines

How EMA GMP Standards Ensure the Safety of Biological and Biosimilar Products

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How EMA GMP Standards Ensure the Safety of Biological and Biosimilar Products Ensuring Safety in Biological and Biosimilar Products with EMA GMP Standards Introduction to Biological and Biosimilar Products Biological products, including vaccines, monoclonal antibodies, and cell-based therapies, are among the most complex pharmaceuticals, requiring advanced techniques and stringent controls during manufacturing. Biosimilars, which are…

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EMA GMP Guidelines

How to Achieve MHRA GMP Compliance for Generic Drugs

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How to Achieve MHRA GMP Compliance for Generic Drugs Achieving MHRA GMP Compliance for Generic Drug Manufacturing Introduction to MHRA GMP Compliance for Generic Drugs Generic drugs play a vital role in the pharmaceutical industry by providing cost-effective alternatives to brand-name medications. However, manufacturing generic drugs requires strict adherence to Good Manufacturing Practices (GMP) to…

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MHRA GMP Guidelines

How to Achieve GMP Compliance in Clinical Trials under NMPA Regulations

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How to Achieve GMP Compliance in Clinical Trials under NMPA Regulations How to Achieve GMP Compliance in Clinical Trials under NMPA Regulations Introduction to NMPA GMP and Clinical Trials Clinical trials are essential for evaluating the safety, efficacy, and quality of new pharmaceutical products before they are approved for widespread use. In China, the National…

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NMPA GMP Guidelines

TGA GMP Compliance for Generic Drug Manufacturers

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TGA GMP Compliance for Generic Drug Manufacturers Ensuring TGA GMP Compliance for Generic Drug Manufacturing in Australia Introduction to TGA GMP and Generic Drug Manufacturing Generic drugs play a vital role in making healthcare accessible by offering cost-effective alternatives to branded medications. In Australia, the Therapeutic Goods Administration (TGA) enforces Good Manufacturing Practices (GMP) to…

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TGA GMP Guidelines

The Role of CAPA in Schedule M (Revised) GMP Compliance

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The Role of CAPA in Schedule M (Revised) GMP Compliance Understanding the Role of CAPA in Ensuring Schedule M (Revised) GMP Compliance Introduction to CAPA and Schedule M (Revised) GMP In pharmaceutical manufacturing, maintaining product quality and regulatory compliance is paramount. Corrective and Preventive Actions (CAPA) is a critical component of Good Manufacturing Practices (GMP)…

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SCHEDULE - M - Revised

How to Align WHO GMP Guidelines with Local Regulatory Requirements

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How to Align WHO GMP Guidelines with Local Regulatory Requirements Strategies for Aligning WHO GMP Guidelines with Local Regulatory Requirements Introduction to WHO GMP and Local Regulatory Requirements The World Health Organization (WHO)’s Good Manufacturing Practices (GMP)) provide a globally recognized framework for ensuring the safety, quality, and efficacy of pharmaceutical products. However, while WHO…

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WHO GMP Guidelines

How to Prepare Your Pharmaceutical Facility for PMDA GMP Inspections

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How to Prepare Your Pharmaceutical Facility for PMDA GMP Inspections How to Prepare Your Pharmaceutical Facility for PMDA GMP Inspections Introduction to PMDA GMP Inspections Pharmaceutical manufacturing is a highly regulated industry, and ensuring that production facilities comply with Good Manufacturing Practices (GMP) is essential for ensuring the safety, efficacy, and quality of drug products….

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PMDA GMP Guidelines

How COFEPRIS GMP Compliance Affects Pharmaceutical Product Development

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How COFEPRIS GMP Compliance Affects Pharmaceutical Product Development How COFEPRIS GMP Compliance Affects Pharmaceutical Product Development Introduction to COFEPRIS GMP and Pharmaceutical Development The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) is the regulatory authority responsible for overseeing the safety, quality, and efficacy of pharmaceutical products in Mexico. As part of its mandate,…

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GMP in Latin America (ANVISA, COFEPRIS)

The Benefits of EMA GMP Certification for International Pharma Operations

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The Benefits of EMA GMP Certification for International Pharma Operations How EMA GMP Certification Drives Success in International Pharma Operations Introduction to EMA GMP Certification The European Medicines Agency (EMA)’s Good Manufacturing Practices (GMP)) certification is a globally recognized standard that ensures the quality, safety, and efficacy of pharmaceutical products. For pharmaceutical companies operating in…

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EMA GMP Guidelines