Category: Lab Notes: Pharmaceutical Industry

International Organization for Standardization (ISO)

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The International Organization for Standardization, commonly known as ISO, is an independent, non-governmental international body that develops and publishes standards…

ISO 45001

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ISO 45001 is the international standard for occupational health and safety (OH&S) management systems.  Published in 2018, it provides a…

ISO 14001

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ISO 14001 is the internationally recognized standard for environmental management systems (EMS). It provides a structured framework that organizations can…

ISO 14971

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ISO 14971 is the internationally recognized standard for the application of risk management to medical devices.  It provides a structured…

ISO 9001

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ISO 9001 is the world’s most widely adopted quality management system (QMS) standard, applicable to organizations of any size, type,…

ISO 13485

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ISO 13485 is an internationally recognized quality management system (QMS) standard specifically designed for organizations involved in the design, development,…

DNA Therapeutics

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DNA Therapeutics represents an innovative field in molecular medicine that utilizes DNA molecules for therapeutic purposes, offering potential treatments for…

RNA Therapeutics

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RNA Therapeutics represents a revolutionary approach in modern medicine that utilizes RNA molecules to target and treat diseases at the…

EudraLex Volume 4 – Annex 5: Manufacture of Immunological Veterinary Medicinal Products

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Annex 5 of EudraLex Volume 4, titled Manufacture of Immunological Veterinary Medicinal Products, provides specific Good Manufacturing Practice (GMP) requirements…

EudraLex Volume 4 – Annex 3: Manufacture of Radiopharmaceuticals

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Annex 3 of EudraLex Volume 4, titled Manufacture of Radiopharmaceuticals, provides specific Good Manufacturing Practice (GMP) guidance for the preparation,…

EudraLex Volume 4 – Annex 9: Manufacture of Liquids, Creams and Ointments

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Annex 9 of EudraLex Volume 4, titled Manufacture of Liquids, Creams and Ointments, provides specialized Good Manufacturing Practice (GMP) guidelines…

EudraLex Volume 4 – Annex 8: Sampling of Starting and Packaging Materials

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Annex 8 of EudraLex Volume 4, titled Sampling of Starting and Packaging Materials, provides specific Good Manufacturing Practice (GMP) guidelines…

EudraLex Volume 4 – Annex 7: Manufacture of Herbal Medicinal Products

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Annex 7 of EudraLex Volume 4, titled Manufacture of Herbal Medicinal Products, provides specific Good Manufacturing Practice (GMP) guidance for…

EudraLex Volume 4 – Annex 6: Manufacture of Medicinal Gases

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Annex 6 of EudraLex Volume 4, titled Manufacture of Medicinal Gases, provides specific Good Manufacturing Practice (GMP) guidelines for the…