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Tag: WHO GMP

Therapeutic Goods Administration (TGA)

Posted on March 12, 2024March 12, 2024 By digi

All about Therapeutic Goods Administration (TGA) – Australia Introduction Welcome to an exploration of the Therapeutic Goods Administration (TGA) in Australia. As Australia’s regulatory authority for therapeutic goods, the TGA plays a vital role in safeguarding public health by regulating medicines, medical devices, and other therapeutic products. A Brief History The TGA was established in…

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GMP Guidelines

Medicines and Healthcare products Regulatory Agency (MHRA)

Posted on March 12, 2024March 12, 2024 By digi

About Medicines and Healthcare products Regulatory Agency (MHRA) – United Kingdom Introduction Welcome to a detailed exploration of the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom. As the regulatory body responsible for ensuring the safety, quality, and efficacy of medicines and medical devices, the MHRA plays a crucial role in safeguarding…

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GMP Guidelines

Health Canada

Posted on March 12, 2024 By digi

  Exploring Health Canada: Safeguarding Public Health in Canada Introduction Welcome to a comprehensive overview of Health Canada, the federal department responsible for ensuring the health and safety of Canadians. Health Canada plays a vital role in regulating and overseeing various aspects of public health, including pharmaceuticals, medical devices, food, and consumer products. A Brief…

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GMP Guidelines

Pharmaceutical and Medical Devices Agency (PMDA)

Posted on March 12, 2024 By digi

  Exploring the Pharmaceutical and Medical Devices Agency (PMDA) Introduction Welcome to a comprehensive exploration of the Pharmaceutical and Medical Devices Agency (PMDA), a critical regulatory body in Japan dedicated to ensuring the safety, efficacy, and quality of pharmaceuticals and medical devices. A Brief History The PMDA traces its origins back to the enactment of…

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GMP Guidelines

European Medicines Agency

Posted on March 12, 2024 By digi

  Exploring the European Medicines Agency (EMA) Introduction Welcome to a journey into the world of the European Medicines Agency (EMA), a pivotal organization in the realm of pharmaceutical regulation and oversight. A Brief History The EMA was established in 1995 with the primary aim of evaluating, supervising, and monitoring medicinal products within the European…

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GMP Guidelines

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  • Qualify HVAC Systems in Warehouses to Maintain GMP Storage Conditions

    Qualify HVAC Systems in Warehouses… Read more

WHO GMP

  • Qualify HVAC Systems in Warehouses to Maintain GMP Storage Conditions
  • Never Handle Rejected Goods During Active GMP Production
  • Ensure QA Oversight in Destruction of GMP Rejected Products
  • Never Use Fiber-Shedding Materials for Machine Cleaning in GMP Areas
  • Review Environmental Monitoring Data Trends to Ensure GMP Compliance
  • Avoid Water Stagnation in GMP Drains and Sinks to Prevent Contamination
  • Test Compressed Air for Microbial Contamination in GMP Utilities
  • Always Perform Swab Sampling After Cleaning Validation
  • Verify Integrity of Double-Door Pass Boxes to Prevent Cross Contamination
  • Never Introduce Uncontrolled Paper Materials into Sterile GMP Areas

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