SOP For Environmental Monitoring Frequency for Microbiological Areas 1.0 OBJECTIVE To establish a scientifically justified and GMP-compliant procedure for defining the frequency of environmental monitoring in microbiological controlled areas to ensure maintenance of cleanroom standards and microbial control. 2.0 SCOPE This SOP is applicable to all classified areas (Grade A, B, C, D) in: Microbiology … Read more
SOP For Washing, Preparation, and Sterilization of Sterile Garments 1.0 Objective 1.1 To establish a procedure for the washing, preparation, sterilization, inspection, and handling of sterile garments to ensure their suitability for use in sterile areas. 2.0 Scope 2.1 This SOP is applicable to all sterile garments used in the Production Department, including their washing, … Read more
SOP For Operation and Cleaning of Laminar Air Flow (LAF) Workstation 1.0 Objective 1.1 To establish a procedure for the operation and cleaning of Laminar Air Flow (LAF) workstations to ensure a controlled, particle-free working environment. 2.0 Scope 2.1 This SOP is applicable to the operation and cleaning of Laminar Air Flow (LAF) workstations in … Read more
SOP For Cleaning of Prefilter of Laminar Air Flow (LAF) 1.0 Objective 1.1 To establish a procedure for the cleaning of prefilters of Laminar Air Flow … Read more
SOP For Fogging of Sterile Area 1.0 Objective 1.1 To establish a procedure for fogging of sterile areas to maintain microbiological control and ensure a contamination-free environment. 2.0 Scope 2.1 This SOP is applicable to the fogging of sterile areas in the Production Department, including associated rooms and airlocks. 3.0 Responsibility 3.1 Operator – Production … Read more
SOP For Cleaning, Maintenance, and Calibration of Stability Chamber 1.0 Objective 1.1 To establish a procedure for the cleaning, maintenance, and calibration of stability chambers to ensure their proper functioning and reliability for stability studies. 2.0 Scope 2.1 This SOP is applicable to all stability chambers used in the Quality Control Department for storage of … Read more
FACILITY USER REQUIREMENT SPECIFICATION (URS) PROTOCOL 1.0 OBJECTIVE The objective of this User Requirement Specification (URS) is to define the functional, operational, environmental, and regulatory requirements for the design, construction, and operation of the pharmaceutical manufacturing facility. This document establishes the minimum requirements for facility layout, cleanroom classification, HVAC systems, utilities, safety systems, and infrastructure … Read more
SOP On Cleaning, Maintenance and Calibration of Cooling Cabinet 1.0 Objective 1.1 To lay down a procedure for the cleaning, maintenance, and calibration of the Cooling Cabinet to ensure proper functioning and reliability. 2.0 Scope 2.1 This SOP is applicable to the cleaning, maintenance, and calibration of the Cooling Cabinet used in the Quality Control … Read more
SOP for Ethylene Oxide (EO) Sterilization Validation 1. Purpose To describe the procedure for validation and routine monitoring of the Ethylene Oxide (EO) sterilization process using the overkill method (AAMI/ISO 11135 Method C) to ensure that the sterilization process consistently achieves the required Sterility Assurance Level (SAL) for medical devices. 2. Scope This SOP applies … Read more
SOP for Handling of Alarm System of Stability Chambers 1.0 Objective 1.1 To lay down the procedure for handling and monitoring the alarm system of stability chambers to ensure prompt response in case of abnormal conditions such as temperature, humidity, or power supply failure. 2.0 Scope 2.1 This SOP is applicable to the operation and … Read more