Tag: SOP for analytical method deviation handling

Analytical Method Development: Specificity Study Using HPLC – V 2.0 SOP for Conducting Specificity Studies Using HPLC in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/074/2025 Supersedes SOP/AMD/074/2022 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 conducting specificity…

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Analytical Method Development: Peak Purity Evaluation using PDA – V 2.0 SOP for Peak Purity Assessment Using PDA Detector in HPLC Method Development Department Analytical Method Development SOP No. SOP/AMD/073/2025 Supersedes SOP/AMD/073/2022 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: Selection of HPLC Column and Mobile Phase – V 2.0 SOP for Selection of HPLC Column and Mobile Phase in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/072/2025 Supersedes SOP/AMD/072/2022 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 provides…

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Analytical Method Development: UPLC Method Development and Optimization – V 2.0 SOP for UPLC Method Development and Optimization in Pharmaceutical Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/071/2025 Supersedes SOP/AMD/071/2022 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 procedure for…

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Analytical Method Development: Isocratic Method Optimization SOP – V 2.0 SOP for Optimization of Isocratic HPLC Methods in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/070/2025 Supersedes SOP/AMD/070/2022 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 a structured approach for the…

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Analytical Method Development: HPLC Gradient Method Development – V 2.0 SOP for Gradient Method Development Using HPLC in Analytical Method Development Laboratory Department Analytical Method Development SOP No. SOP/AMD/069/2025 Supersedes SOP/AMD/069/2022 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 standardized procedure for…

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Analytical Method Development: HPLC Method Development for Finished Product – V 2.0 SOP for HPLC Method Development for Finished Pharmaceutical Products Department Analytical Method Development SOP No. SOP/AMD/068/2025 Supersedes SOP/AMD/068/2022 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 a systematic and regulatory-compliant approach…

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Analytical Method Development: HPLC Method Development for API – V 2.0 SOP for High-Performance Liquid Chromatography (HPLC) Method Development for Active Pharmaceutical Ingredients Department Analytical Method Development SOP No. SOP/AMD/067/2025 Supersedes SOP/AMD/067/2022 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 standardized procedure…

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Analytical Method Development: Conductivity Method Development – V 2.0 SOP for Development of Conductivity-Based Analytical Methods in AMD Laboratory Department Analytical Method Development SOP No. SOP/AMD/066/2025 Supersedes SOP/AMD/066/2022 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 systematic procedure for the development and…

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Analytical Method Development: Refractive Index Method Development – V 2.0 SOP for Development of Refractive Index Method in Analytical Method Development Laboratory Department Analytical Method Development SOP No. SOP/AMD/065/2025 Supersedes SOP/AMD/065/2022 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 methodology for developing…

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