Tag: SOP for method robustness testing

Analytical Method Development: Method Lifecycle Management – V 2.0 SOP for Lifecycle Management of Analytical Methods Department Analytical Method Development SOP No. SOP/AMD/019/2025 Supersedes SOP/AMD/019/2022 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 approach for managing the lifecycle of analytical methods, encompassing…

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Analytical Method Development: Analytical Control Strategy Development – V 2.0 SOP for Developing Analytical Control Strategy in Method Development Department Analytical Method Development SOP No. SOP/AMD/018/2025 Supersedes SOP/AMD/018/2022 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 process for developing an analytical control…

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Analytical Method Development: Use of Design of Experiments (DoE) in Method Development – V 2.0 SOP for Applying Design of Experiments (DoE) in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/017/2025 Supersedes SOP/AMD/017/2022 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…

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Analytical Method Development: QbD-Based Method Development Approach – V 2.0 SOP for Quality by Design (QbD) Approach in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/016/2025 Supersedes SOP/AMD/016/2022 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 outlines the principles and execution strategy…

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Analytical Method Development: Analytical Target Profile (ATP) Documentation – V 2.0 SOP for Documentation of Analytical Target Profile (ATP) in Method Development Department Analytical Method Development SOP No. SOP/AMD/015/2025 Supersedes SOP/AMD/015/2022 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 documenting…

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Analytical Method Development: Preparation of Method Development Report – V 2.0 SOP for Preparation of Method Development Report in Analytical R&D Department Analytical Method Development SOP No. SOP/AMD/014/2025 Supersedes SOP/AMD/014/2022 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 is to define…

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Analytical Method Development: Preparation of Method Development Protocol – V 2.0 SOP for Preparation of Method Development Protocol in Analytical R&D Department Analytical Method Development SOP No. SOP/AMD/013/2025 Supersedes SOP/AMD/013/2022 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 is to define…

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Analytical Method Development: Stability-Indicating Method Development – V 2.0 SOP for Development of Stability-Indicating Analytical Methods Department Analytical Method Development SOP No. SOP/AMD/012/2025 Supersedes SOP/AMD/012/2022 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 systematic procedure for developing and confirming the stability-indicating nature…

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Analytical Method Development: Forced Degradation Studies – V 2.0 SOP for Conducting Forced Degradation Studies in Analytical Method Development Department Analytical Method Development SOP No. SOP/AMD/011/2025 Supersedes SOP/AMD/011/2022 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 conducting forced degradation studies…

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Analytical Method Development: Method Optimization Protocol – V 2.0 SOP for Analytical Method Optimization Protocol in Pharmaceutical Development Department Analytical Method Development SOP No. SOP/AMD/010/2025 Supersedes SOP/AMD/010/2022 Page No. Page 1 of 15 Issue Date 19/05/2025 Effective Date 20/05/2025 Review Date 19/05/2026 1. Purpose To define a systematic approach for optimizing analytical methods developed for…

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