Tag: SOP for system suitability testing

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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Analytical Method Development: Analytical Instrument Calibration in AMD – V 2.0 SOP for Calibration of Analytical Instruments in the AMD Laboratory Department Analytical Method Development SOP No. SOP/AMD/035/2025 Supersedes SOP/AMD/035/2022 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 performing and…

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Analytical Method Development: Software Validation in AMD Lab – V 2.0 SOP for Software Validation Activities in the Analytical Method Development Laboratory Department Analytical Method Development SOP No. SOP/AMD/034/2025 Supersedes SOP/AMD/034/2022 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 validation process for…

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Analytical Method Development: Qualification of Method Development Instruments – V 2.0 SOP for Qualification of Instruments Used in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/033/2025 Supersedes SOP/AMD/033/2022 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 standardized procedure for the…

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Analytical Method Development: Training Matrix for AMD Analysts – V 2.0 SOP for Implementing a Training Matrix for Analysts in the AMD Department Department Analytical Method Development SOP No. SOP/AMD/032/2025 Supersedes SOP/AMD/032/2022 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: Deviation Management during Method Development – V 2.0 SOP for Deviation Management during Analytical Method Development Activities Department Analytical Method Development SOP No. SOP/AMD/031/2025 Supersedes SOP/AMD/031/2022 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 managing deviations that…

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Analytical Method Development: Change Control for Developed Methods – V 2.0 SOP for Managing Change Control of Developed Analytical Methods in AMD Department Analytical Method Development SOP No. SOP/AMD/030/2025 Supersedes SOP/AMD/030/2022 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 managing…

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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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