Tag: Aseptic processing SOP

Sterile Injectable Manufacturing: SOP for Inspection of Injectable Solutions before Filling – V 2.0 Standard Operating Procedure for Inspection of Injectable Solutions before Filling Department Sterile Injectable Manufacturing SOP No. SOP/SIM/034/2025 Supersedes SOP/SIM/034/2022 Page No. Page 1 of 14 Issue Date 18/06/2025 Effective Date 20/06/2025 Review Date 18/06/2026 1. Purpose To lay down the procedure…

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Sterile Injectable Manufacturing: SOP for Filling and Sealing of Injectable Products – V 2.0 Standard Operating Procedure for Filling and Sealing of Injectable Products Department Sterile Injectable Manufacturing SOP No. SOP/SIM/033/2025 Supersedes SOP/SIM/033/2022 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 a standardized procedure…

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Sterile Injectable Manufacturing: SOP for Sterilization of Manufacturing Equipment – V 2.0 Standard Operating Procedure for Sterilization of Manufacturing Equipment Department Sterile Injectable Manufacturing SOP No. SOP/SIM/032/2025 Supersedes SOP/SIM/032/2022 Page No. Page 1 of 14 Issue Date 18/06/2025 Effective Date 20/06/2025 Review Date 18/06/2026 1. Purpose To lay down a standardized procedure for sterilization of…

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Sterile Injectable Manufacturing: SOP for Solution Preparation in Injectable Manufacturing – V 2.0 Standard Operating Procedure for Solution Preparation in Injectable Manufacturing Department Sterile Injectable Manufacturing SOP No. SOP/SIM/031/2025 Supersedes SOP/SIM/031/2022 Page No. Page 1 of 14 Issue Date 18/06/2025 Effective Date 20/06/2025 Review Date 18/06/2026 1. Purpose To define the step-by-step procedure for the…

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Sterile Injectable Manufacturing: SOP for Monitoring Manufacturing Environmental Conditions – V 2.0 Standard Operating Procedure for Monitoring Manufacturing Environmental Conditions Department Sterile Injectable Manufacturing SOP No. SOP/SIM/030/2025 Supersedes SOP/SIM/030/2022 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 procedure for monitoring environmental conditions such…

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Sterile Injectable Manufacturing: SOP for Handling Sterile Components during Manufacturing – V 2.0 Standard Operating Procedure for Handling Sterile Components during Manufacturing Department Sterile Injectable Manufacturing SOP No. SOP/SIM/029/2025 Supersedes SOP/SIM/029/2022 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 establishes a standard method for…

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Sterile Injectable Manufacturing: SOP for Lyophilization Process in Injectable Manufacturing – V 2.0 Standard Operating Procedure for Lyophilization Process in Injectable Manufacturing Department Sterile Injectable Manufacturing SOP No. SOP/SIM/028/2025 Supersedes SOP/SIM/028/2022 Page No. Page 1 of 16 Issue Date 18/06/2025 Effective Date 20/06/2025 Review Date 18/06/2026 1. Purpose To define the procedure for lyophilization (freeze-drying)…

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Sterile Injectable Manufacturing: SOP for Filtration Process in Sterile Injections – V 2.0 Standard Operating Procedure for Filtration Process in Sterile Injections Department Sterile Injectable Manufacturing SOP No. SOP/SIM/027/2025 Supersedes SOP/SIM/027/2022 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 describes the procedure for performing…

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Sterile Injectable Manufacturing: SOP for Aseptic Manufacturing of Prefilled Syringes – V 2.0 Standard Operating Procedure for Aseptic Manufacturing of Prefilled Syringes Department Sterile Injectable Manufacturing SOP No. SOP/SIM/026/2025 Supersedes SOP/SIM/026/2022 Page No. Page 1 of 16 Issue Date 18/06/2025 Effective Date 20/06/2025 Review Date 18/06/2026 1. Purpose The purpose of this Standard Operating Procedure…

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Sterile Injectable Manufacturing: SOP for Intradermal Injection Batch Manufacturing – V 2.0 Standard Operating Procedure for Intradermal Injection Batch Manufacturing Department Sterile Injectable Manufacturing SOP No. SOP/SIM/025/2025 Supersedes SOP/SIM/025/2022 Page No. Page 1 of 14 Issue Date 18/06/2025 Effective Date 20/06/2025 Review Date 18/06/2026 1. Purpose To define the Good Manufacturing Practice (GMP)-compliant process for…

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