Tag: SOP for injectable formulation

Sterile Injectable Manufacturing: SOP for pH Testing of Injectable Products – V 2.0 Standard Operating Procedure for pH Testing of Injectable Products Department Sterile Injectable Manufacturing SOP No. SOP/SIM/064/2025 Supersedes SOP/SIM/064/2022 Page No. Page 1 of 12 Issue Date 18/06/2025 Effective Date 20/06/2025 Review Date 18/06/2026 1. Purpose This SOP defines the procedure for testing…

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Sterile Injectable Manufacturing: SOP for Particulate Matter Testing in Sterile Injections – V 2.0 Standard Operating Procedure for Particulate Matter Testing in Sterile Injections Department Sterile Injectable Manufacturing SOP No. SOP/SIM/063/2025 Supersedes SOP/SIM/063/2022 Page No. Page 1 of 13 Issue Date 18/06/2025 Effective Date 20/06/2025 Review Date 18/06/2026 1. Purpose To lay down the procedure…

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Sterile Injectable Manufacturing: SOP for Endotoxin Testing of Intravenous Injections – V 2.0 Standard Operating Procedure for Endotoxin Testing of Intravenous Injections Department Sterile Injectable Manufacturing SOP No. SOP/SIM/062/2025 Supersedes SOP/SIM/062/2022 Page No. Page 1 of 14 Issue Date 18/06/2025 Effective Date 20/06/2025 Review Date 18/06/2026 1. Purpose To describe the procedure for performing bacterial…

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Sterile Injectable Manufacturing: SOP for Sterility Testing of Injectable Products – V 2.0 Standard Operating Procedure for Sterility Testing of Injectable Products Department Sterile Injectable Manufacturing SOP No. SOP/SIM/061/2025 Supersedes SOP/SIM/061/2022 Page No. Page 1 of 15 Issue Date 18/06/2025 Effective Date 20/06/2025 Review Date 18/06/2026 1. Purpose This SOP outlines the method for conducting…

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Sterile Injectable Manufacturing: SOP for Verification of Cleaning Procedures – V 2.0 Standard Operating Procedure for Verification of Cleaning Procedures Department Sterile Injectable Manufacturing SOP No. SOP/SIM/060/2025 Supersedes SOP/SIM/060/2022 Page No. Page 1 of 14 Issue Date 18/06/2025 Effective Date 20/06/2025 Review Date 18/06/2026 1. Purpose To establish a standardized procedure for verifying cleaning activities…

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Sterile Injectable Manufacturing: SOP for Sanitization of Airlocks in Sterile Manufacturing Facilities – V 2.0 Standard Operating Procedure for Sanitization of Airlocks in Sterile Manufacturing Facilities Department Sterile Injectable Manufacturing SOP No. SOP/SIM/059/2025 Supersedes SOP/SIM/059/2022 Page No. Page 1 of 14 Issue Date 18/06/2025 Effective Date 20/06/2025 Review Date 18/06/2026 1. Purpose To establish a…

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Sterile Injectable Manufacturing: SOP for Cleaning of Solution Preparation Vessels – V 2.0 Standard Operating Procedure for Cleaning of Solution Preparation Vessels Department Sterile Injectable Manufacturing SOP No. SOP/SIM/058/2025 Supersedes SOP/SIM/058/2022 Page No. Page 1 of 12 Issue Date 18/06/2025 Effective Date 20/06/2025 Review Date 18/06/2026 1. Purpose To describe the standardized procedure for cleaning…

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Sterile Injectable Manufacturing: SOP for Cleaning and Maintenance of HEPA Filters in Cleanrooms – V 2.0 Standard Operating Procedure for Cleaning and Maintenance of HEPA Filters in Cleanrooms Department Sterile Injectable Manufacturing SOP No. SOP/SIM/057/2025 Supersedes SOP/SIM/057/2022 Page No. Page 1 of 13 Issue Date 18/06/2025 Effective Date 20/06/2025 Review Date 18/06/2026 1. Purpose To…

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Sterile Injectable Manufacturing: SOP for Cleaning Prefilled Syringe Filling Machines – V 2.0 Standard Operating Procedure for Cleaning Prefilled Syringe Filling Machines Department Sterile Injectable Manufacturing SOP No. SOP/SIM/056/2025 Supersedes SOP/SIM/056/2022 Page No. Page 1 of 14 Issue Date 18/06/2025 Effective Date 20/06/2025 Review Date 18/06/2026 1. Purpose To describe the validated procedure for cleaning…

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Sterile Injectable Manufacturing: SOP for Validation of Cleaning Processes for Sterile Equipment – V 2.0 Standard Operating Procedure for Validation of Cleaning Processes for Sterile Equipment Department Sterile Injectable Manufacturing SOP No. SOP/SIM/055/2025 Supersedes SOP/SIM/055/2022 Page No. Page 1 of 15 Issue Date 18/06/2025 Effective Date 20/06/2025 Review Date 18/06/2026 1. Purpose To define the…

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