Tag: SOP for analytical method change control

Analytical Method Development: SOP for Swab Sampling Method Development – V 2.0 Standard Operating Procedure for Development of Swab Sampling Method for Residue and Microbial Analysis Department Analytical Method Development SOP No. SOP/AMD/233/2025 Supersedes SOP/AMD/233/2022 Page No. Page 1 of 13 Issue Date 21/05/2025 Effective Date 23/05/2025 Review Date 21/05/2026 1. Purpose To define the…

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Analytical Method Development: SOP for Leachables Method Development from Container Closure – V 2.0 Standard Operating Procedure for Development of Analytical Method for Leachables from Container Closure Systems Department Analytical Method Development SOP No. SOP/AMD/232/2025 Supersedes SOP/AMD/232/2022 Page No. Page 1 of 14 Issue Date 21/05/2025 Effective Date 23/05/2025 Review Date 21/05/2026 1. Purpose This…

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Analytical Method Development: SOP for Analytical Method for Extractables from Packaging – V 2.0 Standard Operating Procedure for Development of Analytical Method for Extractables from Packaging Components Department Analytical Method Development SOP No. SOP/AMD/231/2025 Supersedes SOP/AMD/231/2022 Page No. Page 1 of 15 Issue Date 21/05/2025 Effective Date 23/05/2025 Review Date 21/05/2026 1. Purpose To define…

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Analytical Method Development: SOP for Sterility Testing Method Transfer to QC – V 2.0 Standard Operating Procedure for Transfer of Sterility Testing Method to Quality Control Department Department Analytical Method Development SOP No. SOP/AMD/230/2025 Supersedes SOP/AMD/230/2022 Page No. Page 1 of 14 Issue Date 21/05/2025 Effective Date 23/05/2025 Review Date 21/05/2026 1. Purpose To define…

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Analytical Method Development: SOP for Validation of BET Method – V 2.0 Standard Operating Procedure for Validation of Bacterial Endotoxin Test (BET) Method in AMD Department Analytical Method Development SOP No. SOP/AMD/229/2025 Supersedes SOP/AMD/229/2022 Page No. Page 1 of 13 Issue Date 21/05/2025 Effective Date 23/05/2025 Review Date 21/05/2026 1. Purpose This SOP provides a…

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Analytical Method Development: SOP for Identification of Objectionable Microorganisms – V 2.0 Standard Operating Procedure for Identification of Objectionable Microorganisms in Non-Sterile Products Department Analytical Method Development SOP No. SOP/AMD/228/2025 Supersedes SOP/AMD/228/2022 Page No. Page 1 of 13 Issue Date 21/05/2025 Effective Date 23/05/2025 Review Date 21/05/2026 1. Purpose This SOP defines the procedure for…

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Analytical Method Development: SOP for Method Suitability for Non-Sterile Products – V 2.0 Standard Operating Procedure for Method Suitability Testing of Non-Sterile Products in AMD Department Analytical Method Development SOP No. SOP/AMD/227/2025 Supersedes SOP/AMD/227/2022 Page No. Page 1 of 13 Issue Date 21/05/2025 Effective Date 23/05/2025 Review Date 21/05/2026 1. Purpose This SOP describes the…

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Analytical Method Development: SOP for Antimicrobial Activity Test Method Development – V 2.0 Standard Operating Procedure for Development of Antimicrobial Activity Testing Methods in AMD Department Analytical Method Development SOP No. SOP/AMD/226/2025 Supersedes SOP/AMD/226/2022 Page No. Page 1 of 13 Issue Date 21/05/2025 Effective Date 23/05/2025 Review Date 21/05/2026 1. Purpose This SOP provides a…

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Analytical Method Development: SOP for Bioburden Method Development for APIs – V 2.0 Standard Operating Procedure for Bioburden Testing Method Development for Active Pharmaceutical Ingredients (APIs) Department Analytical Method Development SOP No. SOP/AMD/225/2025 Supersedes SOP/AMD/225/2022 Page No. Page 1 of 13 Issue Date 21/05/2025 Effective Date 23/05/2025 Review Date 21/05/2026 1. Purpose This SOP outlines…

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Analytical Method Development: SOP for Environmental Isolate Challenge Testing – V 2.0 Standard Operating Procedure for Environmental Isolate Challenge Testing in AMD Department Analytical Method Development SOP No. SOP/AMD/224/2025 Supersedes SOP/AMD/224/2022 Page No. Page 1 of 12 Issue Date 21/05/2025 Effective Date 23/05/2025 Review Date 21/05/2026 1. Purpose This SOP outlines the procedure for utilizing…

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