Tag: Quality Management Systems (QMS) in pharma

How Schedule M (Revised) GMP Standards Support Generic Drug Manufacturing in India

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How Schedule M (Revised) GMP Standards Support Generic Drug Manufacturing in India Enhancing Generic Drug Manufacturing in India with Schedule M (Revised) GMP Standards Introduction to Generic Drug Manufacturing in India India is renowned as the “pharmacy of the world,” with a significant share in the global generic drug market. Generic drugs provide affordable healthcare…

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SCHEDULE - M - Revised

How ANVISA GMP Ensures Quality Control for Pharmaceuticals in Brazil

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How ANVISA GMP Ensures Quality Control for Pharmaceuticals in Brazil How ANVISA GMP Ensures Quality Control for Pharmaceuticals in Brazil Introduction to ANVISA and the Role of GMP in Quality Control The National Health Surveillance Agency (ANVISA) is the regulatory authority in Brazil that is responsible for overseeing the safety, efficacy, and quality of pharmaceutical…

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GMP in Latin America (ANVISA, COFEPRIS)

How NMPA GMP Helps Prevent the Production of Counterfeit Drugs

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How NMPA GMP Helps Prevent the Production of Counterfeit Drugs How NMPA GMP Helps Prevent the Production of Counterfeit Drugs Introduction to NMPA GMP and Counterfeit Drugs Counterfeit drugs pose a significant threat to public health, as they can be ineffective, harmful, or even lethal to patients. In response to this growing problem, regulatory bodies…

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NMPA GMP Guidelines

How TGA GMP Standards Support the Launch of New Pharmaceutical Products

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How TGA GMP Standards Support the Launch of New Pharmaceutical Products The Role of TGA GMP Standards in Facilitating New Drug Launches Introduction to TGA GMP and Pharmaceutical Product Launches Launching a new pharmaceutical product is a complex process that requires rigorous planning, compliance, and quality assurance. The Therapeutic Goods Administration (TGA) in Australia enforces…

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TGA GMP Guidelines

Case Study: Achieving WHO GMP Certification in a Pharmaceutical Facility

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Case Study: Achieving WHO GMP Certification in a Pharmaceutical Facility How a Pharmaceutical Facility Achieved WHO GMP Certification: A Case Study Introduction to WHO GMP Certification Achieving WHO GMP certification is a significant milestone for pharmaceutical manufacturers, signifying adherence to the highest standards of quality, safety, and efficacy. The certification not only builds trust among…

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WHO GMP Guidelines

How to Integrate PMDA GMP with Other International Regulatory Requirements

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How to Integrate PMDA GMP with Other International Regulatory Requirements How to Integrate PMDA GMP with Other International Regulatory Requirements Introduction to PMDA GMP and Global Regulatory Compliance The pharmaceutical industry operates in an increasingly globalized environment, with companies often marketing products in multiple countries and regions. For manufacturers, ensuring compliance with different regulatory requirements…

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PMDA GMP Guidelines

How EMA GMP Standards Promote Good Manufacturing Practices in Biotech

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How EMA GMP Standards Promote Good Manufacturing Practices in Biotech Promoting Excellence in Biotech Manufacturing with EMA GMP Standards Introduction to EMA GMP Standards in Biotech Biotechnology is revolutionizing the pharmaceutical industry, enabling the development of complex therapies such as monoclonal antibodies, gene therapies, and cell-based treatments. Due to the intricate nature of these products,…

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EMA GMP Guidelines

How MHRA GMP Standards Contribute to Pharmaceutical R&D Processes

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How MHRA GMP Standards Contribute to Pharmaceutical R&D Processes Enhancing Pharmaceutical R&D with MHRA GMP Standards Introduction to MHRA GMP in Pharmaceutical R&D Research and Development (R&D) is the foundation of the pharmaceutical industry, driving the discovery and development of innovative drugs and therapies. Ensuring compliance with the Medicines and Healthcare products Regulatory Agency (MHRA)…

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MHRA 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 Understanding the Role of Environmental Control Systems in Ensuring Schedule M (Revised) GMP Compliance Introduction to Environmental Control in Pharmaceutical Manufacturing Environmental control systems are a cornerstone of Good Manufacturing Practices (GMP) in pharmaceutical manufacturing, ensuring that products are manufactured in a contamination-free…

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SCHEDULE - M - Revised

How to Integrate TGA GMP Compliance with Other Regulatory Requirements

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How to Integrate TGA GMP Compliance with Other Regulatory Requirements Strategies for Aligning TGA GMP Compliance with Global Regulatory Standards Introduction to TGA GMP and Regulatory Integration The Therapeutic Goods Administration (TGA) enforces Good Manufacturing Practices (GMP) in Australia to ensure the quality, safety, and efficacy of pharmaceutical products. However, pharmaceutical companies operating in multiple…

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TGA GMP Guidelines