Tag: GMP inspections

How Schedule M (Revised) GMP Enhances Risk Management in Pharma Manufacturing

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How Schedule M (Revised) GMP Enhances Risk Management in Pharma Manufacturing Strengthening Risk Management in Pharmaceutical Manufacturing with Schedule M (Revised) GMP Introduction to Risk Management in Pharmaceutical Manufacturing In pharmaceutical manufacturing, managing risks is essential to ensure product quality, patient safety, and regulatory compliance. Risks can arise at various stages, from raw material procurement…

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SCHEDULE - M - Revised

The Role of EMA GMP in Promoting Drug Safety Across the European Union

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The Role of EMA GMP in Promoting Drug Safety Across the European Union Ensuring Drug Safety Across the EU with EMA GMP Standards Introduction to EMA GMP and Drug Safety Drug safety is a cornerstone of public health, ensuring that medicines are effective, free from contamination, and consistently manufactured. The European Medicines Agency (EMA)’s Good…

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EMA GMP Guidelines

How to Ensure GMP Compliance in MHRA’s Multi-Site Inspections

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How to Ensure GMP Compliance in MHRA’s Multi-Site Inspections Ensuring GMP Compliance During MHRA Multi-Site Inspections Introduction to MHRA Multi-Site Inspections The Medicines and Healthcare products Regulatory Agency (MHRA) conducts Good Manufacturing Practice (GMP) inspections to ensure pharmaceutical manufacturers meet regulatory standards for product quality, safety, and efficacy. Multi-site inspections, which involve reviewing operations at…

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MHRA GMP Guidelines

How TGA GMP Guidelines Ensure the Manufacture of Sterile Products

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How TGA GMP Guidelines Ensure the Manufacture of Sterile Products Ensuring Sterility in Pharmaceutical Manufacturing with TGA GMP Guidelines Introduction to TGA GMP and Sterile Products Sterile products, such as injectables, eye drops, and certain biologics, play a critical role in healthcare. Given their direct interaction with sensitive body systems, ensuring sterility is paramount to…

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TGA GMP Guidelines

How to Align ANVISA GMP with Other Latin American and Global GMP Standards

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How to Align ANVISA GMP with Other Latin American and Global GMP Standards How to Align ANVISA GMP with Other Latin American and Global GMP Standards Introduction to GMP Harmonization Good Manufacturing Practices (GMP) are essential for ensuring that pharmaceutical products are produced consistently and safely. In many countries, regulatory bodies like ANVISA (Brazil’s National…

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GMP in Latin America (ANVISA, COFEPRIS)

Best Practices for WHO GMP Compliance in Pharmaceutical Operations

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Best Practices for WHO GMP Compliance in Pharmaceutical Operations Essential Practices for Achieving WHO GMP Compliance in Pharmaceutical Manufacturing Introduction to WHO GMP Compliance The World Health Organization (WHO)’s Good Manufacturing Practices (GMP)) set the global standard for ensuring the quality, safety, and efficacy of pharmaceutical products. Compliance with WHO GMP is essential for maintaining…

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WHO GMP Guidelines

The Role of Technology in Achieving PMDA GMP Compliance

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The Role of Technology in Achieving PMDA GMP Compliance The Role of Technology in Achieving PMDA GMP Compliance Introduction to PMDA GMP Compliance and Technology Good Manufacturing Practices (GMP) are essential for ensuring that pharmaceutical products are produced consistently, safely, and to the highest quality standards. In Japan, the Pharmaceutical and Medical Devices Agency (PMDA)…

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PMDA GMP Guidelines

The Role of Environmental Control Systems in Schedule M (Revised) GMP Compliance

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The Role of Environmental Control Systems in Schedule M (Revised) GMP Compliance The Role of Environmental Control Systems in Schedule M (Revised) GMP Compliance Introduction to Schedule M (Revised) GMP and Environmental Control Systems In pharmaceutical manufacturing, compliance with Good Manufacturing Practices (GMP) is essential to ensure that products meet safety, efficacy, and quality standards….

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NMPA GMP Guidelines

How EMA GMP Standards Address the Issue of Counterfeit Drugs in Europe

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How EMA GMP Standards Address the Issue of Counterfeit Drugs in Europe Combating Counterfeit Drugs in Europe with EMA GMP Standards Introduction to Counterfeit Drugs and EMA GMP Standards Counterfeit drugs pose a significant threat to public health, undermining the safety, efficacy, and integrity of pharmaceutical products. These falsified medicines often contain incorrect ingredients, improper…

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EMA GMP Guidelines

How TGA GMP Standards Impact the Pharmaceutical Supply Chain in Australia

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How TGA GMP Standards Impact the Pharmaceutical Supply Chain in Australia The Influence of TGA GMP Standards on Australia’s Pharmaceutical Supply Chain Introduction to TGA GMP and the Pharmaceutical Supply Chain The Therapeutic Goods Administration (TGA) enforces Good Manufacturing Practices (GMP) to ensure that pharmaceutical products meet stringent safety, quality, and efficacy standards. These regulations…

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TGA GMP Guidelines