Tag: SOP for method robustness testing

Analytical Method Development: Technology Transfer of Analytical Methods – V 2.0 SOP for Technology Transfer of Analytical Methods in AMD Department Analytical Method Development SOP No. SOP/AMD/029/2025 Supersedes SOP/AMD/029/2022 Page No. Page 1 of 15 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose This SOP describes the procedure for transferring analytical methods…

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Analytical Method Development: Handling Non-Pharmacopoeial Test Methods – V 2.0 SOP for Handling Non-Pharmacopoeial Test Methods in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/028/2025 Supersedes SOP/AMD/028/2022 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 development, evaluation, justification,…

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Analytical Method Development: Review and Approval of Method Development Data – V 2.0 SOP for Review and Approval of Method Development Data in AMD Department Analytical Method Development SOP No. SOP/AMD/027/2025 Supersedes SOP/AMD/027/2022 Page No. Page 1 of 14 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose The purpose of this SOP…

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Analytical Method Development: Troubleshooting Methods Developed in AMD – V 2.0 SOP for Troubleshooting Analytical Methods Developed in the AMD Department Department Analytical Method Development SOP No. SOP/AMD/026/2025 Supersedes SOP/AMD/026/2022 Page No. Page 1 of 15 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose This SOP provides a systematic procedure for troubleshooting…

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Analytical Method Development: System Suitability Testing Parameters Design – V 2.0 SOP for Designing System Suitability Testing Parameters in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/025/2025 Supersedes SOP/AMD/025/2022 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 designing,…

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Analytical Method Development: Preparation and Use of Placebos in Method Development – V 2.0 SOP for Preparation and Use of Placebos in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/024/2025 Supersedes SOP/AMD/024/2022 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…

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Analytical Method Development: Preparation and Use of Working Standards in AMD – V 2.0 SOP for Preparation and Use of Working Standards in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/023/2025 Supersedes SOP/AMD/023/2022 Page No. Page 1 of 15 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose This SOP describes…

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Analytical Method Development: Validation-Readiness Evaluation of Developed Methods – V 2.0 SOP for Evaluation of Validation-Readiness for Developed Analytical Methods Department Analytical Method Development SOP No. SOP/AMD/022/2025 Supersedes SOP/AMD/022/2022 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 evaluating whether an…

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Analytical Method Development: Reference Standard Qualification for AMD – V 2.0 SOP for Qualification of Reference Standards in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/021/2025 Supersedes SOP/AMD/021/2022 Page No. Page 1 of 15 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose This SOP defines the procedure for qualification, documentation,…

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Analytical Method Development: Drafting Analytical Specifications – V 2.0 SOP for Drafting Analytical Specifications in Method Development Department Analytical Method Development SOP No. SOP/AMD/020/2025 Supersedes SOP/AMD/020/2022 Page No. Page 1 of 15 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose The purpose of this SOP is to outline the systematic procedure for…

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