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
SOP on Operation, Calibration, Cleaning and Maintenance of Bacteriological IncubatorMake: Thermolab 1.0 Objective 1.1 To lay down the procedure for Operation, Calibration, Cleaning and Maintenance of the Bacteriological Incubator used in the Microbiology Laboratory. 2.0 Scope 2.1 This SOP is applicable to the Bacteriological Incubator installed in the Microbiology Laboratory of the Quality Control Department. … Read more
SOP on Viable Particulate Monitoring – MLT Testing and Other Areas – Microbiology 1.0 Objective 1.1 To lay down the procedure for Viable Particulate Monitoring in MLT (Microbial Limit Test) Testing and other designated areas of the Microbiology Laboratory to ensure environmental compliance with acceptable microbiological limits. 2.0 Scope 2.1 This SOP is applicable to … Read more
SOP on Viable Particulate Monitoring – Sterility Testing Area 1.0 Objective 1.1 To lay down the procedure for Viable Particulate Monitoring in the Sterility Testing Area of the Microbiology Laboratory to ensure compliance with acceptable limits of total viable count. 2.0 Scope 2.1 This SOP is applicable to viable particulate (microbial) monitoring of the Sterility … Read more
SOP on Operation, Temperature Verification, Cleaning and Maintenance of Dry Bath Incubator 1.0 Objective 1.1 To lay down the procedure for operation, temperature verification (calibration check), cleaning, and maintenance of the Dry Bath Incubator used in the Microbiology Laboratory. 2.0 Scope 2.1 This SOP is applicable to the operation, temperature verification, cleaning, and maintenance of … Read more
SOP on Gram Staining 1.0 Objective To lay down the procedure for performing Gram Staining for differentiation of Gram-positive and Gram-negative microorganisms in the Microbiology Laboratory. 2.0 Scope This SOP is applicable to Gram Staining performed in the Microbiology Laboratory for identification and characterization of microorganisms. 3.0 Responsibility Microbiologist or above of Microbiology Laboratory: Preparation … Read more