Tag: SOP for injectable formulation

Manufacturing Operations: SOP for Bulk Filtration of Injectable Solutions – V 2.0 Standard Operating Procedure for Bulk Filtration of Injectable Solutions Department Manufacturing Operations SOP No. SOP/MO/122/2025 Supersedes SOP/MO/122/2022 Page No. Page 1 of 14 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose To establish a standard and regulatory-compliant procedure for bulk…

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Manufacturing Validation: SOP for Validation of Sterilization Cycle in Manufacturing – V 2.0 Standard Operating Procedure for Validation of Sterilization Cycle in Manufacturing Department Manufacturing Validation SOP No. SOP/MV/121/2025 Supersedes SOP/MV/121/2022 Page No. Page 1 of 14 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose To establish a standard methodology for the…

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Formulation Development: SOP for Documentation in Product Development – V 2.0 Standard Operating Procedure for Documentation in Product Development Department Formulation Development SOP No. SOP/FD/120/2025 Supersedes SOP/FD/120/2022 Page No. Page 1 of 14 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose To establish a standard procedure for preparing, reviewing, storing, and managing…

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Formulation Development: SOP for Risk Management in Product Development Lifecycle – V 2.0 Standard Operating Procedure for Risk Management in Product Development Lifecycle Department Formulation Development SOP No. SOP/FD/119/2025 Supersedes SOP/FD/119/2022 Page No. Page 1 of 15 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose The purpose of this SOP is to…

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Sterile Injectable Manufacturing: SOP for Evaluating Freeze-Drying Parameters in Injectable Development – V 2.0 Standard Operating Procedure for Evaluating Freeze-Drying Parameters in Injectable Development Department Formulation & Development SOP No. SOP/SIM/118/2025 Supersedes SOP/SIM/118/2022 Page No. Page 1 of 13 Issue Date 18/06/2025 Effective Date 20/06/2025 Review Date 18/06/2026 1. Purpose To outline the process for…

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Sterile Injectable Manufacturing: SOP for Selection of Container Closure Systems for Prefilled Syringes – V 2.0 Standard Operating Procedure for Selection of Container Closure Systems for Prefilled Syringes Department Formulation & Development SOP No. SOP/SIM/117/2025 Supersedes SOP/SIM/117/2022 Page No. Page 1 of 12 Issue Date 18/06/2025 Effective Date 20/06/2025 Review Date 18/06/2026 1. Purpose To…

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Sterile Injectable Manufacturing: SOP for Scale-Up Studies in Injection Formulation – V 2.0 Standard Operating Procedure for Scale-Up Studies in Injection Formulation Department Product Development SOP No. SOP/SIM/116/2025 Supersedes SOP/SIM/116/2022 Page No. Page 1 of 12 Issue Date 18/06/2025 Effective Date 20/06/2025 Review Date 18/06/2026 1. Purpose To define the procedure for conducting scale-up studies…

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Sterile Injectable Manufacturing: SOP for Analytical Method Development for Injectable Products – V 2.0 Standard Operating Procedure for Analytical Method Development for Injectable Products Department Analytical Development SOP No. SOP/SIM/115/2025 Supersedes SOP/SIM/115/2022 Page No. Page 1 of 13 Issue Date 18/06/2025 Effective Date 20/06/2025 Review Date 18/06/2026 1. Purpose To define a structured approach for…

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Sterile Injectable Manufacturing: SOP for Evaluating Injection Viscosity and Compatibility – V 2.0 Standard Operating Procedure for Evaluating Injection Viscosity and Compatibility Department Product Development SOP No. SOP/SIM/114/2025 Supersedes SOP/SIM/114/2022 Page No. Page 1 of 12 Issue Date 18/06/2025 Effective Date 20/06/2025 Review Date 18/06/2026 1. Purpose To define a standardized procedure for evaluating the…

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Sterile Injectable Manufacturing: SOP for Selection of Excipients for Injectable Products – V 2.0 Standard Operating Procedure for Selection of Excipients for Injectable Products Department Product Development SOP No. SOP/SIM/113/2025 Supersedes SOP/SIM/113/2022 Page No. Page 1 of 10 Issue Date 18/06/2025 Effective Date 20/06/2025 Review Date 18/06/2026 1. Purpose To establish a consistent approach for…

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