Tag: Cleanroom SOP for injectables

Quality Control: SOP for Periodic Calibration of QC Equipment – V 2.0 Standard Operating Procedure for Periodic Calibration of QC Equipment Department Quality Control SOP No. SOP/QC/170/2025 Supersedes SOP/QC/170/2022 Page No. Page 1 of 15 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose This Standard Operating Procedure (SOP) describes the method for…

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Quality Control: SOP for Handling Out-of-Specification (OOS) Results in QC – V 2.0 Standard Operating Procedure for Handling Out-of-Specification (OOS) Results in Quality Control Department Quality Control SOP No. SOP/QC/169/2025 Supersedes SOP/QC/169/2022 Page No. Page 1 of 16 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose This Standard Operating Procedure (SOP) describes…

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Quality Control: SOP for Monitoring Container Closure System Integrity – V 2.0 Standard Operating Procedure for Monitoring Container Closure System Integrity in Sterile Injectables Department Quality Control SOP No. SOP/QC/168/2025 Supersedes SOP/QC/168/2022 Page No. Page 1 of 15 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose This SOP defines the process for…

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Quality Control: SOP for Analyzing Residual Solvents in Injectable Formulations – V 2.0 Standard Operating Procedure for Analyzing Residual Solvents in Injectable Formulations Department Quality Control SOP No. SOP/QC/167/2025 Supersedes SOP/QC/167/2022 Page No. Page 1 of 15 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose This SOP describes the procedure for identification…

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Quality Control: SOP for Conducting Repeat Testing in QC Labs – V 2.0 Standard Operating Procedure for Conducting Repeat Testing in QC Laboratories Department Quality Control SOP No. SOP/QC/166/2025 Supersedes SOP/QC/166/2022 Page No. Page 1 of 13 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose This Standard Operating Procedure (SOP) outlines the…

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Sterile Injectable Manufacturing: SOP for Functional Testing of Prefilled Syringes – V 2.0 Standard Operating Procedure for Functional Testing of Prefilled Syringes Department Sterile Injectable Manufacturing SOP No. SOP/SIM/165/2025 Supersedes SOP/SIM/165/2022 Page No. Page 1 of 14 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose This Standard Operating Procedure (SOP) outlines the…

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Sterile Injectable Manufacturing: SOP for Validation of Analytical Testing Methods – V 2.0 Standard Operating Procedure for Validation of Analytical Testing Methods Department Sterile Injectable Manufacturing SOP No. SOP/SIM/164/2025 Supersedes SOP/SIM/164/2022 Page No. Page 1 of 14 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose This SOP defines the procedures and requirements…

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Sterile Injectable Manufacturing: SOP for Spectroscopic Analysis of Injectable Solutions – V 2.0 Standard Operating Procedure for Spectroscopic Analysis of Injectable Solutions Department Sterile Injectable Manufacturing SOP No. SOP/SIM/163/2025 Supersedes SOP/SIM/163/2022 Page No. Page 1 of 14 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose This SOP defines the standardized procedure for…

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Sterile Injectable Manufacturing: SOP for Impurity Profiling of Sterile Products – V 2.0 Standard Operating Procedure for Impurity Profiling of Sterile Products Department Sterile Injectable Manufacturing SOP No. SOP/SIM/162/2025 Supersedes SOP/SIM/162/2022 Page No. Page 1 of 15 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose This SOP outlines the standard procedures for…

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Sterile Injectable Manufacturing: SOP for Osmolality Testing of Injectable Products – V 2.0 Standard Operating Procedure for Osmolality Testing of Injectable Products Department Sterile Injectable Manufacturing SOP No. SOP/SIM/161/2025 Supersedes SOP/SIM/161/2022 Page No. Page 1 of 14 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose This SOP defines the method for determining…

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