Tag: SOP for analytical method transfer protocol

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,…

Read More “Analytical Method Development: Reference Standard Qualification for AMD – V 2.0” »

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…

Read More “Analytical Method Development: Drafting Analytical Specifications – V 2.0” »

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…

Read More “Analytical Method Development: Method Lifecycle Management – V 2.0” »

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…

Read More “Analytical Method Development: Analytical Control Strategy Development – V 2.0” »

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…

Read More “Analytical Method Development: Use of Design of Experiments (DoE) in Method Development – V 2.0” »

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…

Read More “Analytical Method Development: QbD-Based Method Development Approach – V 2.0” »

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…

Read More “Analytical Method Development: Analytical Target Profile (ATP) Documentation – V 2.0” »

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…

Read More “Analytical Method Development: Preparation of Method Development Report – V 2.0” »

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…

Read More “Analytical Method Development: Preparation of Method Development Protocol – V 2.0” »

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…

Read More “Analytical Method Development: Stability-Indicating Method Development – V 2.0” »