Tag: Corrective and Preventive Actions (CAPA) for GMP

Common WHO GMP Violations and How to Avoid Them

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Common WHO GMP Violations and How to Avoid Them Understanding Common WHO GMP Violations and Strategies to Avoid Them Introduction to WHO GMP Compliance Adhering to the World Health Organization (WHO)’s Good Manufacturing Practices (GMP)) is essential for ensuring the quality, safety, and efficacy of pharmaceutical products. However, achieving and maintaining compliance can be challenging,…

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WHO GMP Guidelines

How to Leverage NMPA GMP for Regulatory Approvals in China

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How to Leverage NMPA GMP for Regulatory Approvals in China How to Leverage NMPA GMP for Regulatory Approvals in China Introduction to NMPA GMP and Regulatory Approvals in China The pharmaceutical industry in China is tightly regulated by the National Medical Products Administration (NMPA), formerly known as the China Food and Drug Administration (CFDA). NMPA…

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NMPA GMP Guidelines

How PMDA GMP Ensures Compliance in Pharma Manufacturing Operations

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How PMDA GMP Ensures Compliance in Pharma Manufacturing Operations How PMDA GMP Ensures Compliance in Pharma Manufacturing Operations Introduction to PMDA GMP Compliance in Pharmaceutical Manufacturing In the highly regulated pharmaceutical industry, ensuring that drug products are manufactured in accordance with Good Manufacturing Practices (GMP) is critical to ensuring their safety, efficacy, and quality. In…

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PMDA GMP Guidelines

TGA GMP Compliance for Pharmaceutical Manufacturers Exporting to Australia

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TGA GMP Compliance for Pharmaceutical Manufacturers Exporting to Australia How Pharmaceutical Manufacturers Can Ensure TGA GMP Compliance for Export to Australia Introduction to TGA GMP Compliance for Export Pharmaceutical manufacturers exporting to Australia must adhere to the stringent Good Manufacturing Practices (GMP) standards enforced by the Therapeutic Goods Administration (TGA). These regulations ensure that imported…

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TGA GMP Guidelines

The Impact of ANVISA GMP on the Brazilian Pharmaceutical Market

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The Impact of ANVISA GMP on the Brazilian Pharmaceutical Market The Impact of ANVISA GMP on the Brazilian Pharmaceutical Market Introduction to ANVISA and the Role of GMP in Brazil The National Health Surveillance Agency (ANVISA) is Brazil’s regulatory body responsible for ensuring the safety, quality, and efficacy of pharmaceutical products, including drugs, medical devices,…

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GMP in Latin America (ANVISA, COFEPRIS)

How to Prepare for EMA GMP Inspections in Multi-Site Pharmaceutical Operations

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How to Prepare for EMA GMP Inspections in Multi-Site Pharmaceutical Operations Comprehensive Guide to Preparing for EMA GMP Inspections Across Multi-Site Pharmaceutical Operations Introduction to EMA GMP Inspections Ensuring compliance with the European Medicines Agency (EMA)’s Good Manufacturing Practices (GMP)) is essential for pharmaceutical companies operating across multiple sites. EMA GMP inspections assess whether manufacturing…

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EMA GMP Guidelines

How Schedule M (Revised) GMP Helps with Drug Stability and Shelf Life

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How Schedule M (Revised) GMP Helps with Drug Stability and Shelf Life Ensuring Drug Stability and Shelf Life Through Schedule M (Revised) GMP Guidelines Introduction to Drug Stability and Shelf Life Drug stability and shelf life are critical parameters in pharmaceutical manufacturing. They ensure that a drug maintains its intended efficacy, safety, and quality throughout…

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SCHEDULE - M - Revised

The Role of WHO GMP in Regulatory Approvals for Emerging Markets

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The Role of WHO GMP in Regulatory Approvals for Emerging Markets How WHO GMP Guidelines Facilitate Regulatory Approvals in Emerging Markets Introduction to WHO GMP and Emerging Markets Emerging markets are rapidly becoming vital players in the global pharmaceutical industry, driven by growing healthcare demands and expanding manufacturing capabilities. However, gaining regulatory approval in these…

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WHO GMP Guidelines

How to Ensure GMP Compliance with MHRA Guidelines for Biologics

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How to Ensure GMP Compliance with MHRA Guidelines for Biologics Ensuring GMP Compliance with MHRA Guidelines for Biologics Introduction to MHRA GMP Guidelines for Biologics Biologics, or biopharmaceuticals, are complex medicinal products derived from living organisms. These include vaccines, monoclonal antibodies, gene therapies, and cell-based products. Due to their intricate nature and sensitivity to environmental…

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MHRA GMP Guidelines

The Role of Technology in Achieving NMPA GMP Compliance

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The Role of Technology in Achieving NMPA GMP Compliance The Role of Technology in Achieving NMPA GMP Compliance Introduction to NMPA GMP and Technology The pharmaceutical industry is one of the most highly regulated sectors globally, with strict standards in place to ensure the safety, efficacy, and quality of drugs. In China, the National Medical…

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NMPA GMP Guidelines