SOP For Cleaning and Disinfection of Microbiology Laboratory 1.0 Objective 1.1 To establish a procedure for cleaning and disinfection of the Microbiology Laboratory to maintain hygienic conditions and ensure environmental control. 2.0 Scope 2.1 This SOP is applicable to cleaning and disinfection of all areas within the Microbiology Laboratory, including General Microbiology Lab, Sterility Testing … Read more
SOP for Preparation and Usage of Disinfectants 1.0 Objective 1.1 To establish a procedure for the preparation, filtration, labeling, storage, and usage of disinfectants in the Microbiology Section to ensure effective environmental control and contamination prevention. 2.0 Scope 2.1 This SOP is applicable to the preparation and use of disinfectants in the Sterility Testing Area, … Read more
SOP For Operation, Cleaning and Maintenance of Fogger and Fogging of Microbiology Testing Areas 1.0 Objective 1.1 To establish a procedure for the operation, cleaning, and maintenance of the fogger and for carrying out fogging activities in Microbiology Testing Areas to ensure effective environmental decontamination. 2.0 Scope 2.1 This SOP is applicable to the operation, … Read more
SOP for Operation, Cleaning and Maintenance of Microscope 1.0 Objective 1.1 To establish a procedure for the proper operation, cleaning, and maintenance of the microscope to ensure accurate observations and to maintain the instrument in good working condition. 2.0 Scope 2.1 This SOP is applicable to the operation, cleaning, and maintenance of microscopes used in … Read more
SOP For Viable Particle Monitoring of Drain Points – Sterile Product Manufacturing Facility 1.0 Objective 1.1 To establish a procedure for performing viable particle monitoring of drain points in the Sterile Product Manufacturing Facility to ensure microbiological control and compliance with applicable regulatory requirements. 2.0 Scope 2.1 This SOP is applicable to viable particle monitoring … Read more
SOP on Out of Specification (OOS) Results in Microbiology Laboratory 1.0 Objective To establish a systematic procedure for reporting, investigation, evaluation, and disposition of Out of Specification (OOS) results generated in the Microbiology Laboratory. 2.0 Scope 2.1 This SOP is applicable to OOS results arising from: Microbial Limit Test (MLT) Sterility Testing Bacterial Endotoxin Test … Read more
SOP For Handling of Microbiological Data Deviation (MDD) in Microbiology Laboratory 1.0 Objective 1.1 To lay down a systematic procedure for identification, reporting, investigation, evaluation, and closure of Microbiological Data Deviations (MDD) observed in the Microbiology Laboratory. 2.0 Scope 2.1 This SOP is applicable to all microbiological deviations arising from the following activities: Environmental Monitoring … Read more
SOP on Container Closure Integrity Testing (CCIT) for Dry Powder for Injection 1.0 Objective 1.1 To lay down the procedure for performing Container Closure Integrity Testing (CCIT) for Dry Powder for Injection using Chemical (Dye Ingress) Method and Microbial Challenge Study. 2.0 Scope 2.1 This SOP is applicable to Container Closure Integrity Testing of Dry … Read more
SOP FOR ANALYST QUALIFICATION FOR MICROBIOLOGICAL ANALYSIS 1.0 OBJECTIVE To establish a standardized procedure for qualification and requalification of analysts performing microbiological analysis to ensure competency, accuracy, and compliance with regulatory requirements. 2.0 SCOPE This SOP applies to all microbiologists working in the Microbiology Department involved in microbiological testing activities. 3.0 RESPONSIBILITY 3.1 Trainee Officer … Read more
SOP for PROCEDURE FOR MICROBIAL LIMIT TEST 1.0 OBJECTIVE To establish a standardized procedure for determining microbial load, including specified pathogenic microorganisms, in raw materials and finished products using the Microbial Limit Test (MLT). 2.0 SCOPE This procedure applies to the analysis of microbial contamination and specified pathogens in raw materials and finished pharmaceutical products … Read more