Tag: SOP for method robustness testing

Analytical Method Development: Method Feasibility Evaluation – V 2.0 Standard Operating Procedure for Method Feasibility Evaluation in Analytical Development Department Analytical Method Development SOP No. SOP/AMD/009/2025 Supersedes SOP/AMD/009/2022 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 the feasibility of…

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Analytical Method Development: Selection of Mobile Phase for Chromatographic Techniques – V 2.0 SOP for Selecting Mobile Phases in Chromatographic Method Development Department Analytical Method Development SOP No. SOP/AMD/008/2025 Supersedes SOP/AMD/008/2022 Page No. Page 1 of 14 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose To define the systematic approach for selecting…

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Analytical Method Development: Development of Test Procedures for Formulations – V 2.0 SOP for Developing Test Procedures for Pharmaceutical Formulations Department Analytical Method Development SOP No. SOP/AMD/007/2025 Supersedes SOP/AMD/007/2022 Page No. Page 1 of 15 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose To establish a standardized procedure for the development of…

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Analytical Method Development: Development of Test Procedures for API – V 2.0 Standard Operating Procedure for Development of Test Procedures for Active Pharmaceutical Ingredients (API) Department Analytical Method Development SOP No. SOP/AMD/006/2025 Supersedes SOP/AMD/006/2022 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…

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Analytical Method Development: Selection of Analytical Techniques – V 2.0 Standard Operating Procedure for Selection of Analytical Techniques in Method Development Department Analytical Method Development SOP No. SOP/AMD/005/2025 Supersedes SOP/AMD/005/2022 Page No. Page 1 of 13 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose This SOP provides guidance for selecting appropriate analytical…

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Analytical Method Development: Literature Review for Method Development – V 2.0 Comprehensive SOP for Literature Review in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/004/2025 Supersedes SOP/AMD/004/2022 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 guidance for conducting comprehensive literature reviews…

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Analytical Method Development: Handling of Pharmacopoeial Monographs – V 2.0 Standard Operating Procedure for Handling of Pharmacopoeial Monographs in AMD Department Analytical Method Development SOP No. SOP/AMD/003/2025 Supersedes SOP/AMD/003/2022 Page No. Page 1 of 13 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose To establish a controlled procedure for the identification, review,…

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Analytical Method Development: Risk Assessment in Analytical Method Development – V 2.0 Structured SOP for Conducting Risk Assessment in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/002/2025 Supersedes SOP/AMD/002/2022 Page No. Page 1 of 14 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose To outline a systematic approach for conducting…

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Analytical Method Development: Preparation of AMD Master Plan – V 2.0 Comprehensive SOP for Developing the Analytical Method Development (AMD) Master Plan Department Analytical Method Development SOP No. SOP/AMD/001/2025 Supersedes SOP/AMD/001/2022 Page No. Page 1 of 12 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose To define the process for preparation, review,…

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