Tag: SOP for environmental monitoring in aseptic area

Sterile Injection Manufacturing: SOP for Handling Packing Line Discrepancies – V 2.0

Sterile Injection Manufacturing: SOP for Handling Packing Line Discrepancies – V 2.0 Standard Operating Procedure for Handling Packing Line Discrepancies Department Sterile Injection Manufacturing SOP No. SOP/SIM/200/2025 Supersedes SOP/SIM/200/2022 Page No. Page 1 of 14 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose To provide a standard procedure for the identification, investigation,…

Injectables V 2.0

Sterile Injection Manufacturing: SOP for Documentation of Packaging Line Performance – V 2.0

Sterile Injection Manufacturing: SOP for Documentation of Packaging Line Performance – V 2.0 Standard Operating Procedure for Documentation of Packaging Line Performance Department Sterile Injection Manufacturing SOP No. SOP/SIM/199/2025 Supersedes SOP/SIM/199/2022 Page No. Page 1 of 13 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose This SOP defines the standard process for…

Injectables V 2.0

Sterile Injection Manufacturing: SOP for Ensuring Tamper-Evident Sealing on Syringe Packs – V 2.0

Sterile Injection Manufacturing: SOP for Ensuring Tamper-Evident Sealing on Syringe Packs – V 2.0 Standard Operating Procedure for Ensuring Tamper-Evident Sealing on Syringe Packs Department Sterile Injection Manufacturing SOP No. SOP/SIM/198/2025 Supersedes SOP/SIM/198/2022 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 consistent and…

Injectables V 2.0

Sterile Injection Manufacturing: SOP for Packaging of Temperature-Sensitive Injectable Products – V 2.0

Sterile Injection Manufacturing: SOP for Packaging of Temperature-Sensitive Injectable Products – V 2.0 Standard Operating Procedure for Packaging of Temperature-Sensitive Injectable Products Department Sterile Injection Manufacturing SOP No. SOP/SIM/197/2025 Supersedes SOP/SIM/197/2022 Page No. Page 1 of 14 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose To define the procedure for the proper…

Injectables V 2.0

Sterile Injection Manufacturing: SOP for Inspection of Cartons Used for Injectable Packing – V 2.0

Sterile Injection Manufacturing: SOP for Inspection of Cartons Used for Injectable Packing – V 2.0 Standard Operating Procedure for Inspection of Cartons Used for Injectable Packing Department Sterile Injection Manufacturing SOP No. SOP/SIM/196/2025 Supersedes SOP/SIM/196/2022 Page No. Page 1 of 12 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose To establish a…

Injectables V 2.0

Sterile Injection Manufacturing: SOP for Sealing Quality Testing during Packing – V 2.0

Sterile Injection Manufacturing: SOP for Sealing Quality Testing during Packing – V 2.0 Standard Operating Procedure for Sealing Quality Testing during Packing Department Sterile Injection Manufacturing SOP No. SOP/SIM/195/2025 Supersedes SOP/SIM/195/2022 Page No. Page 1 of 13 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose To establish a standardized procedure for performing…

Injectables V 2.0

Sterile Injection Manufacturing: SOP for Use of Automated Labeling Machines in Packing Lines – V 2.0

Sterile Injection Manufacturing: SOP for Use of Automated Labeling Machines in Packing Lines – V 2.0 Standard Operating Procedure for Use of Automated Labeling Machines in Packing Lines Department Sterile Injection Manufacturing SOP No. SOP/SIM/194/2025 Supersedes SOP/SIM/194/2022 Page No. Page 1 of 14 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose To…

Injectables V 2.0

Packaging: SOP for Final Labeling and Batch Coding of Injectable Vials – V 2.0

Packaging: SOP for Final Labeling and Batch Coding of Injectable Vials – V 2.0 Standard Operating Procedure for Final Labeling and Batch Coding of Injectable Vials Department Packaging SOP No. SOP/PKG/193/2025 Supersedes SOP/PKG/193/2022 Page No. Page 1 of 14 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose To define the procedure for…

Injectables V 2.0

Packaging: SOP for Visual Inspection of Packed Injectable Products – V 2.0

Packaging: SOP for Visual Inspection of Packed Injectable Products – V 2.0 Standard Operating Procedure for Visual Inspection of Packed Injectable Products Department Packaging SOP No. SOP/PKG/192/2025 Supersedes SOP/PKG/192/2022 Page No. Page 1 of 14 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose To define the procedure for performing visual inspection of…

Injectables V 2.0

Packaging: SOP for Conducting Line Clearance before Packing Operations – V 2.0

Packaging: SOP for Conducting Line Clearance before Packing Operations – V 2.0 Standard Operating Procedure for Line Clearance before Packaging Operations Department Packaging SOP No. SOP/PKG/191/2025 Supersedes SOP/PKG/191/2022 Page No. Page 1 of 14 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose To define the procedure for performing line clearance prior to…

Injectables V 2.0