QA & QC

SOP of LAL Reagent Objective To lay down the procedure Confirmation of Labeled LAL Reagent Sensitivity.  Scope This SOP is applicable for Confirmation of Labeled LAL Reagent Sensitivity tested in Microbiology Laboratory. (Pharmaceutical Company Name). Responsibility Microbiologist or above of Microbiology Laboratory. Head – Microbiology section / Nominee. Accountability Head …

SOP On Temperature Monitoring of Microbiology Equipment’s Objective To lay down the procedure for Temperature Monitoring of Microbiology Equipment’s. Scope This SOP is applicable for Temperature Monitoring of Microbiology Equipment’s like incubators and refrigerator in Microbiology Laboratory of (Pharmaceutical Company Name). Responsibility Microbiologist or above of Microbiology Laboratory: Preparation of SOP. …

SOP of Total Viable Spore Count Test for Biological Indicators Objective To lay down the procedure for Total Viable Spore Count and Resistance Performance test for Biological Indicators  Scope This SOP is applicable for Total Viable Spore Count and Resistance Performance test for Biological Indicators of (Pharmaceutical Company Name). Responsibility …

SOP of Culture Suspension Preparation and Preservation Objective To lay down the procedure for Preparation and Preservation of 10-100 CFU’s/0.l ml Culture Suspension. Scope This SOP is applicable for Preparation and Preservation of 10-100 CFU’s /0.1 ml Culture Suspension in Microbiology Laboratory of (Pharmaceutical Company Name). Responsibility Microbiologist or above …

SOP on Media growth Promotion, Inhibition, and Sterility Check Objective To lay down the procedure for Media Growth Promotion, Inhibition, and Sterility Check. Scope This SOP is applicable for Media Growth Promotion, Inhibition, and Sterility Checks in the Microbiology Laboratory of (Pharmaceutical Company Name). Responsibility Chemist or above of QC …

SOP of Reference cultures Maintenance and usage Objective SOP on Maintenance and usage of Reference cultures.  Scope This SOP is applicable for Maintenance and usage of Reference cultures. Of (Pharmaceutical Company Name). Responsibility Chemist or above of QC laboratory. Head – Microbiology Section. Accountability Head – Quality Control. Abbreviations and …

SOP on Viable Particulate Monitoring – Sterility Testing Objective To lay down the procedure for Viable Particulate Monitoring – Sterility Testing Area – Microbiology. Scope This SOP is applicable for Viable Particulate Monitoring in Sterility Testing Area of Microbiology lab of (Pharmaceutical Company Name). Responsibility Chemist or above of Microbiology …

ASEPTIC ENVIRONMENT: NONVIABLE VS VIABLE MONITORING Any contamination poses a risk to the contents of the cleanroom and, in some industries, is a threat to the end-user or product. What Is An Aseptic Environment? Aseptic is defined as being “free from contamination caused by harmful bacteria, viruses, or other microorganisms. …

SOP Sterile Garment Cabinet Objective To lay down the procedure for the routine operation, cleaning and maintenance of the Sterile Garment Cabinet (SGC).  Scope This SOP is applicable operation cleaning and maintenance of the Sterile Garment Cabinet present in Microbiology Laboratory of (Pharmaceutical Company Name). Responsibility Chemist or above of …

SOP of LAF Operation, Calibration, Cleaning, and Maintenance Objective To lay down the procedure for Operation, Calibration, Cleaning and Maintenance of LAF. Scope This SOP is applicable for Operation, Calibration, Cleaning and Maintenance of LAF in Microbiology Laboratory of (Pharmaceutical Company Name). Responsibility Microbiologist or above of Microbiology Laboratory: Preparation …

SOP of Gram Staining Objective: To lay down the procedure for Gram Staining This SOP is applicable for Gram Staining in Microbiology Laboratory of (Pharmaceutical Company Name). Responsibility Microbiologist or above of Microbiology Laboratory: Preparation of SOP. Head – Microbiology section / Nominee: Checking of the SOP. Accountability Head – Quality …

SOP of Dry Bath Incubator Objective: To lay down a procedure for operation, calibration, cleaning and maintenance of Dry bath incubator Scope This SOP is applicable for operation, calibration, cleaning and maintenance of dry bath incubator in Microbiology Laboratory of (Pharmaceutical Company Name). Responsibility Microbiologist or above of Microbiology Laboratory. …

SOP on Spore Staining Objective: This SOP is applicable for spore staining in Microbiology Laboratory of (Pharmaceutical Company Name). Responsibility Microbiologist or above Microbiology laboratory: Preparation of the SOP. Head – Microbiology section/ Nominee: Checking of the SOP. Accountability Head – Quality Control/ Nominee: Compliance of SOPs. Abbreviations and Definitions …

SOP on Motility test This SOP is applicable for Motility test by Hanging drop Method in Microbiology Laboratory of (Pharmaceutical Company Name). Responsibility Microbiologist or above of Microbiology Laboratory: Preparation of SOP. Head – Microbiology section / Nominee: Checking of the SOP. Accountability Head – Quality Control / Nominee: Compliance …

Safety in Microbiology Safety is of utmost importance in a microbiology laboratory to prevent any potential infections caused by the microorganisms under study. It is crucial to be aware that certain reagents, equipment, and procedures used in the lab can be hazardous. Therefore, it is essential to follow proper protocols …

Disinfectants Disinfectants are substances utilized on inanimate objects to eliminate living microorganisms present on them. Its are substances utilized on inanimate objects to eliminate living microorganisms present on them. Types of disinfectants Air Disinfectants Alcohol Disinfectants Oxidizing Disinfectants Its include: Air disinfectants, Alcohols, Aldehydes, Oxidizing agents, Phenolics, Quaternary ammonium compounds, …

MICROPIPETTES  -CLEANING, OPERATION AND CALIBRATION To outline the procedure for Cleaning, Operation and calibration of micro pipettes. SCOPE This procedure for cleaning, Operation and calibration of micropipettes is applicable in microbiology section. RESPONSIBILITY Originating department shall be responsible: To Cleaning, Operation and Calibration of Micropipettes as per SOP. Head Quality …

SOP in Microbiology for operation, cleaning and maintenance of Fogger Objective To lay down the procedure for operation, cleaning and maintenance of Fogger and Fogging of Microbiology Testing Areas. Scope This SOP is applicable for operation, cleaning and maintenance of Fogger and Fogging of Microbiology Testing Areas (Pharmaceutical Company Name). …

SOP of Lactophenol cotton blue staining for identification of fungi To lay down the procedure for performing the Lactophenol cotton blue staining technique for identification of fungi. Scope This SOP is applicable for the identification of the fungal colonies in Microbiology Laboratory of (Pharmaceutical Company Name). Responsibility Microbiologist or above …

SOP of Fogging of Microbiology Testing Areas Objective To lay down the procedure for Fogging of Microbiology Testing Areas. Scope This SOP is applicable for Fogging of Microbiology Testing Areas in Microbiology Laboratory of (Pharmaceutical Company Name). Responsibility Chemist or above of Microbiology Laboratory. Head – Microbiology Section. Accountability Head …