Tag: Elixir regulatory guidelines

Elixir Department: SOP for Sample Retention Procedure – V 2.0 Standard Operating Procedure for Sample Retention Procedure in Elixir Manufacturing Department Elixir Department SOP No. SOP/ELX/239/2025 Supersedes SOP/ELX/239/2022 Page No. Page 1 of 7 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To establish a procedure for the retention of reference and…

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Elixir Department: SOP for Reporting QC Out-of-Specification Results – V 2.0 Standard Operating Procedure for Reporting QC Out-of-Specification (OOS) Results in Elixir Testing Department Elixir Department SOP No. SOP/ELX/238/2025 Supersedes SOP/ELX/238/2022 Page No. Page 1 of 8 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To outline the procedure for identifying, documenting,…

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Elixir Department: SOP for Shelf-Life Testing Protocol – V 2.0 Standard Operating Procedure for Shelf-Life Testing Protocol of Elixir Formulations Department Elixir Department SOP No. SOP/ELX/236/2025 Supersedes SOP/ELX/236/2022 Page No. Page 1 of 8 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To establish a standardized procedure for the design, execution, and…

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Elixir Department: SOP for Verification of Test Results – V 2.0 Standard Operating Procedure for Verification of Test Results in Elixir Quality Control Department Elixir Department SOP No. SOP/ELX/237/2025 Supersedes SOP/ELX/237/2022 Page No. Page 1 of 7 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To define the procedure for the systematic…

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Elixir Department: SOP for Stability Indicating Testing – V 2.0 Standard Operating Procedure for Stability Indicating Testing of Elixir Formulations Department Elixir Department SOP No. SOP/ELX/235/2025 Supersedes SOP/ELX/235/2022 Page No. Page 1 of 8 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To define the procedure for conducting stability indicating testing of…

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Elixir Department: SOP for Alcohol Evaporation Rate – V 2.0 Standard Operating Procedure for Determining Alcohol Evaporation Rate in Elixir Formulations Department Elixir Department SOP No. SOP/ELX/234/2025 Supersedes SOP/ELX/234/2022 Page No. Page 1 of 7 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To define the procedure for evaluating the rate of…

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Elixir Department: SOP for pH Drift Analysis – V 2.0 Standard Operating Procedure for pH Drift Analysis in Elixir Formulations Department Elixir Department SOP No. SOP/ELX/233/2025 Supersedes SOP/ELX/233/2022 Page No. Page 1 of 7 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To define the procedure for performing pH drift analysis of…

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Elixir Department: SOP for Conductivity Testing – V 2.0 Standard Operating Procedure for Conductivity Testing in Elixir Formulations Department Elixir Department SOP No. SOP/ELX/232/2025 Supersedes SOP/ELX/232/2022 Page No. Page 1 of 7 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To define a standardized procedure for measuring the electrical conductivity of elixir…

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Elixir Department: SOP for pKa Determination – V 2.0 Standard Operating Procedure for pKa Determination of Active Ingredients in Elixir Formulations Department Elixir Department SOP No. SOP/ELX/231/2025 Supersedes SOP/ELX/231/2022 Page No. Page 1 of 8 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To describe the procedure for determining the acid dissociation…

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Elixir Department: SOP for Preservative Content Assay – V 2.0 Standard Operating Procedure for Assay of Preservative Content in Elixir Formulations Department Elixir Department SOP No. SOP/ELX/230/2025 Supersedes SOP/ELX/230/2022 Page No. Page 1 of 8 Issue Date 11/04/2025 Effective Date 15/04/2025 Review Date 11/04/2026 1. Purpose To outline a validated procedure for the quantitative estimation…

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