FACILITY USER REQUIREMENT SPECIFICATION (URS) PROTOCOL

by

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

by

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

by

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

by

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

SOP on handling of rinse and swab sample

by

SOP on handling of rinse and swab sample 1.0 Objective 1.1 To establish a procedure for the receipt, recording, analysis, and handling of rinse and swab samples in the Quality Control (QC) Department. 2.0 Scope 2.1 This SOP is applicable to the handling, documentation, and analysis of rinse and swab samples received in the Quality … Read more

SOP For Retesting of Primary Packaging Material (PPM)

by

SOP For Retesting of Primary Packaging Material (PPM) 1.0 Objective 1.1 To lay down the procedure for retesting of Primary Packaging Materials (PPM) to ensure their continued suitability and compliance with approved specifications before use. 2.0 Scope 2.1 This SOP is applicable to the retesting of Primary Packaging Materials in the Quality Control (QC) Department. … Read more

Analytical Instrument Qualification For HPLC System

by

Analytical Instrument Qualification For HPLC System 1.0 Objective To lay down a procedure for qualification of the Shimadzu HPLC system to ensure that the instrument is installed correctly, operates as intended, and consistently performs according to predefined specifications and regulatory requirements. 2.0 Scope This procedure is applicable to qualification of Shimadzu High-Performance Liquid Chromatography (HPLC) … Read more

PREPARATION, REVIEW, CONTROL AND REVISION OF SITE MASTER FILE (SMF)

by

PREPARATION, REVIEW, CONTROL AND REVISION OF SITE MASTER FILE (SMF) 1.0 OBJECTIVE To describe the procedure for preparation, review, approval, control, and revision of the Site Master File (SMF). 2.0 SCOPE This SOP is applicable to the preparation and maintenance of the Site Master File covering: Facility Premises Equipment Personnel Quality Management System Utilities 3.0 … Read more

Hazard Analysis and Critical Control Point – HACCP

by

Hazard Analysis and Critical Control Point – HACCP 1.0 OBJECTIVE To lay down the procedure for conducting Hazard Analysis and Critical Control Point (HACCP) study to identify, evaluate, and control hazards that may affect the safety, quality, and efficacy of products. 2.0 SCOPE This procedure is applicable to all products manufactured at the facility and … Read more

SOP ON HAZARD ANALYSIS AND CRITICAL CONTROL POINTS (HACCP)

by

SOP ON HAZARD ANALYSIS AND CRITICAL CONTROL POINTS (HACCP) 1.0 OBJECTIVE To lay down the procedure for conducting Hazard Analysis and Critical Control Point (HACCP) study to systematically identify, evaluate, and control hazards that may affect the safety, quality, and efficacy of products. 2.0 SCOPE This procedure is applicable to all products manufactured at the … Read more