Tag: SOP for method transfer

Analytical Method Development: Titrimetric Assay Development for Alkalinity – V 2.0 SOP for Titrimetric Assay Development for Alkalinity in the AMD Laboratory Department Analytical Method Development SOP No. SOP/AMD/045/2025 Supersedes SOP/AMD/045/2022 Page No. Page 1 of 14 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose This SOP outlines the systematic approach to…

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Analytical Method Development: Titrimetric Assay Development for Acidity – V 2.0 SOP for Titrimetric Assay Development for Acidity in the AMD Department Department Analytical Method Development SOP No. SOP/AMD/044/2025 Supersedes SOP/AMD/044/2022 Page No. Page 1 of 14 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose This SOP describes the procedure for developing,…

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Analytical Method Development: pH Method Development for Formulations – V 2.0 SOP for pH Method Development of Pharmaceutical Formulations in AMD Laboratory Department Analytical Method Development SOP No. SOP/AMD/043/2025 Supersedes SOP/AMD/043/2022 Page No. Page 1 of 14 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose This SOP describes the process for developing…

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Analytical Method Development: pH Method Development for API – V 2.0 SOP for pH Method Development of Active Pharmaceutical Ingredients in AMD Laboratory Department Analytical Method Development SOP No. SOP/AMD/042/2025 Supersedes SOP/AMD/042/2022 Page No. Page 1 of 14 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose This SOP defines the procedure for…

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Analytical Method Development: Preparation of Reagents and Volumetric Solutions – V 2.0 SOP for Preparation of Reagents and Volumetric Solutions in AMD Laboratory Department Analytical Method Development SOP No. SOP/AMD/041/2025 Supersedes SOP/AMD/041/2022 Page No. Page 1 of 14 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose This SOP describes the procedure for…

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Analytical Method Development: Integration with Product Development Team – V 2.0 SOP for Cross-Functional Integration with Product Development Team in the AMD Department Department Analytical Method Development SOP No. SOP/AMD/040/2025 Supersedes SOP/AMD/040/2022 Page No. Page 1 of 14 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose This SOP establishes the framework for…

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Analytical Method Development: Archiving Method Development Reports – V 2.0 SOP for Archiving Analytical Method Development Reports in the AMD Department Department Analytical Method Development SOP No. SOP/AMD/039/2025 Supersedes SOP/AMD/039/2022 Page No. Page 1 of 14 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose This SOP describes the procedure for the review,…

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Analytical Method Development: Handling of AMD Method Notebooks – V 2.0 SOP for Handling Method Development Notebooks in the AMD Department Department Analytical Method Development SOP No. SOP/AMD/038/2025 Supersedes SOP/AMD/038/2022 Page No. Page 1 of 14 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose This SOP describes the procedures for the issuance,…

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Analytical Method Development: Data Integrity in Method Development – V 2.0 SOP for Ensuring Data Integrity During Analytical Method Development Activities Department Analytical Method Development SOP No. SOP/AMD/037/2025 Supersedes SOP/AMD/037/2022 Page No. Page 1 of 14 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose This SOP outlines the principles and procedures required…

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Analytical Method Development: Reagent Qualification for Method Development – V 2.0 SOP for Qualification of Reagents Used in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/036/2025 Supersedes SOP/AMD/036/2022 Page No. Page 1 of 14 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose This SOP defines the procedure for qualifying reagents…

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