Tag: SOP for analytical method change control

Analytical Method Development: SOP for Endotoxin Limit Test by Kinetic-Turbidimetric Method – V 2.0 Standard Operating Procedure for Bacterial Endotoxin Test Using Kinetic-Turbidimetric Method Department Analytical Method Development SOP No. SOP/AMD/223/2025 Supersedes SOP/AMD/223/2022 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…

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Analytical Method Development: SOP for Microbial Identification via Biochemical Testing – V 2.0 Standard Operating Procedure for Microbial Identification Using Biochemical Testing in AMD Department Analytical Method Development SOP No. SOP/AMD/222/2025 Supersedes SOP/AMD/222/2022 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 standardized…

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Analytical Method Development: SOP for Preservative Efficacy Testing Method Development – V 2.0 Standard Operating Procedure for Developing Methods for Preservative Efficacy Testing in AMD Department Analytical Method Development SOP No. SOP/AMD/221/2025 Supersedes SOP/AMD/221/2022 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 the…

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Analytical Method Development: SOP for Floating or Swelling Dosage Form Dissolution Method – V 2.0 Standard Operating Procedure for Dissolution Method Development of Floating and Swelling Dosage Forms Department Analytical Method Development SOP No. SOP/AMD/220/2025 Supersedes SOP/AMD/220/2022 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 Filter Compatibility Testing in Dissolution – V 2.0 Standard Operating Procedure for Filter Compatibility Testing in Dissolution Method Development Department Analytical Method Development SOP No. SOP/AMD/219/2025 Supersedes SOP/AMD/219/2022 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…

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Analytical Method Development: SOP for Apparatus Suitability and RPM Optimization – V 2.0 Standard Operating Procedure for Evaluating Apparatus Suitability and Optimizing RPM in Dissolution Method Development Department Analytical Method Development SOP No. SOP/AMD/218/2025 Supersedes SOP/AMD/218/2022 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…

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Analytical Method Development: SOP for Dosage Form De-aggregation Evaluation – V 2.0 Standard Operating Procedure for Evaluation of Dosage Form De-aggregation in Dissolution Studies Department Analytical Method Development SOP No. SOP/AMD/217/2025 Supersedes SOP/AMD/217/2022 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 a standardized…

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Analytical Method Development: SOP for Sink Condition Verification in Dissolution Method – V 2.0 Standard Operating Procedure for Verifying Sink Conditions in Dissolution Method Development Department Analytical Method Development SOP No. SOP/AMD/216/2025 Supersedes SOP/AMD/216/2022 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 a…

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Analytical Method Development: SOP for Media pH Selection and Buffer Capacity Evaluation – V 2.0 Standard Operating Procedure for pH Selection and Buffer Capacity Evaluation in Dissolution Media Department Analytical Method Development SOP No. SOP/AMD/215/2025 Supersedes SOP/AMD/215/2022 Page No. Page 1 of 12 Issue Date 21/05/2025 Effective Date 23/05/2025 Review Date 21/05/2026 1. Purpose This…

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Analytical Method Development: SOP for Dissolution Media Filtering and Degassing – V 2.0 Standard Operating Procedure for Filtering and Degassing Dissolution Media in AMD Department Analytical Method Development SOP No. SOP/AMD/214/2025 Supersedes SOP/AMD/214/2022 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 provides a standardized…

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