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
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) 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 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) 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 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) 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
SOP for HANDLING OF NON-CONFORMANCE OBSERVATION 1.0 OBJECTIVE The purpose of this SOP is to establish a systematic procedure for identification, reporting, investigation, classification, control, and closure of non-conformances observed during product processing, and to prevent their recurrence in future manufacturing processes or product delivery. 2.0 SCOPE This procedure is applicable to all types of … Read more
SOP FOR CONTAMINATION CONTROL STRATEGY (CCS) 1.0 OBJECTIVE 1.1 To describe the procedure for establishing, implementing, and maintaining a comprehensive Contamination Control Strategy (CCS) to ensure that risks of microbial, particulate, and endotoxin/pyrogen contamination are systematically identified, evaluated, controlled, monitored, and continuously improved in accordance with the principles of EU GMP Annex 1. 2.0 SCOPE … Read more