Tag: SOP for gowning in cleanroom

Manufacturing: SOP for Training Personnel on In-Process Monitoring – V 2.0

Manufacturing: SOP for Training Personnel on In-Process Monitoring – V 2.0 Standard Operating Procedure for Training Personnel on In-Process Monitoring Department Manufacturing SOP No. SOP/MFG/180/2025 Supersedes SOP/MFG/180/2022 Page No. Page 1 of 13 Issue Date 24/06/2025 Effective Date 25/06/2025 Review Date 24/06/2026 1. Purpose To establish a standardized procedure for training manufacturing personnel in in-process…

Injectables V 2.0

Manufacturing: SOP for Ensuring Compliance with Critical Process Parameters – V 2.0

Manufacturing: SOP for Ensuring Compliance with Critical Process Parameters – V 2.0 Standard Operating Procedure for Ensuring Compliance with Critical Process Parameters Department Manufacturing SOP No. SOP/MFG/179/2025 Supersedes SOP/MFG/179/2022 Page No. Page 1 of 14 Issue Date 24/06/2025 Effective Date 25/06/2025 Review Date 24/06/2026 1. Purpose To define a standardized procedure for identifying, monitoring, and…

Injectables V 2.0

Manufacturing: SOP for Documentation of In-Process Observations – V 2.0

Manufacturing: SOP for Documentation of In-Process Observations – V 2.0 Standard Operating Procedure for Documentation of In-Process Observations Department Manufacturing SOP No. SOP/MFG/178/2025 Supersedes SOP/MFG/178/2022 Page No. Page 1 of 12 Issue Date 24/06/2025 Effective Date 25/06/2025 Review Date 24/06/2026 1. Purpose This SOP outlines the process for documenting all in-process observations made during the…

Injectables V 2.0

Manufacturing: SOP for Temperature and Humidity Monitoring during Production – V 2.0

Manufacturing: SOP for Temperature and Humidity Monitoring during Production – V 2.0 Standard Operating Procedure for Temperature and Humidity Monitoring during Production Department Manufacturing SOP No. SOP/MFG/177/2025 Supersedes SOP/MFG/177/2022 Page No. Page 1 of 13 Issue Date 24/06/2025 Effective Date 25/06/2025 Review Date 24/06/2026 1. Purpose To lay down a procedure for monitoring and controlling…

Injectables V 2.0

Manufacturing: SOP for Controlling Particle Contamination in Aseptic Areas – V 2.0

Manufacturing: SOP for Controlling Particle Contamination in Aseptic Areas – V 2.0 Standard Operating Procedure for Controlling Particle Contamination in Aseptic Areas Department Manufacturing SOP No. SOP/MFG/176/2025 Supersedes SOP/MFG/176/2022 Page No. Page 1 of 14 Issue Date 24/06/2025 Effective Date 25/06/2025 Review Date 24/06/2026 1. Purpose This SOP establishes a standardized procedure for preventing and…

Injectables V 2.0

Manufacturing: SOP for Conducting Microbial Monitoring during Filling Process – V 2.0

Manufacturing: SOP for Conducting Microbial Monitoring during Filling Process – V 2.0 Standard Operating Procedure for Conducting Microbial Monitoring during Filling Process Department Manufacturing SOP No. SOP/MFG/175/2025 Supersedes SOP/MFG/175/2022 Page No. Page 1 of 15 Issue Date 24/06/2025 Effective Date 25/06/2025 Review Date 24/06/2026 1. Purpose This SOP defines the process for conducting microbial monitoring…

Injectables V 2.0

Manufacturing: SOP for Ensuring Proper Mixing during Solution Preparation – V 2.0

Manufacturing: SOP for Ensuring Proper Mixing during Solution Preparation – V 2.0 Standard Operating Procedure for Ensuring Proper Mixing during Solution Preparation Department Manufacturing SOP No. SOP/MFG/174/2025 Supersedes SOP/MFG/174/2022 Page No. Page 1 of 15 Issue Date 24/06/2025 Effective Date 25/06/2025 Review Date 24/06/2026 1. Purpose This SOP describes the procedure for ensuring uniform and…

Injectables V 2.0

In-Process Control: SOP for Inspection of Filled Syringes before Sealing – V 2.0

In-Process Control: SOP for Inspection of Filled Syringes before Sealing – V 2.0 Standard Operating Procedure for Inspection of Filled Syringes before Sealing Department In-Process Control SOP No. SOP/IPC/173/2025 Supersedes SOP/IPC/173/2022 Page No. Page 1 of 14 Issue Date 24/06/2025 Effective Date 25/06/2025 Review Date 24/06/2026 1. Purpose To define the procedure for inspecting filled…

Injectables V 2.0

In-Process Control: SOP for Real-Time Monitoring of Vial Fill Levels – V 2.0

In-Process Control: SOP for Real-Time Monitoring of Vial Fill Levels – V 2.0 Standard Operating Procedure for Real-Time Monitoring of Vial Fill Levels Department In-Process Control SOP No. SOP/IPC/172/2025 Supersedes SOP/IPC/172/2022 Page No. Page 1 of 15 Issue Date 24/06/2025 Effective Date 25/06/2025 Review Date 24/06/2026 1. Purpose This SOP describes the process and responsibilities…

Injectables V 2.0

In-Process Control: SOP for Ensuring Accuracy of In-Process Weight Checks – V 2.0

In-Process Control: SOP for Ensuring Accuracy of In-Process Weight Checks – V 2.0 Standard Operating Procedure for Ensuring Accuracy of In-Process Weight Checks Department In-Process Control SOP No. SOP/IPC/171/2025 Supersedes SOP/IPC/171/2022 Page No. Page 1 of 14 Issue Date 25/06/2025 Effective Date 27/06/2025 Review Date 25/06/2026 1. Purpose The purpose of this SOP is to…

Injectables V 2.0