Category: Microbiology

SOP on Personnel Qualification for Aseptic Processing and Sterility Testing Area

Posted on By Pharmaceutical Guidanace

Objective: To lay down the procedure for Personnel Qualification to enter and work in Aseptic Processing area and Sterility Testing Area. Scope: This SOP is applicable for Personnel Qualification to work in Aseptic Processing and Sterility testing Area. Responsibility: Chemist or above of Microbiology Laboratory. Head – Microbiology Section. Accountability: Head – Quality Control Head…

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Microbiology

SOP on Viable Particle Monitoring of Drain Points– Sterile Product Manufacturing Facility

Posted on By Pharmaceutical Guidanace

Objective: To lay down the procedure for Viable Particulate Monitoring of Drain Points – Sterile Product Manufacturing Facility Scope: This SOP is applicable for Viable Particle Monitoring of Drain Points – Sterile Product Manufacturing Facility Responsibility: Officer or above of Microbiology Laboratory. Head – Microbiology section / Nominee. Accountability: Head – Quality Control / Nominee….

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Microbiology

Sampling and testing of Sterile surgical Gloves

Posted on By Pharmaceutical Guidanace

Objective: To lay down the procedure for Sampling and testing of sterile surgical gloves. Scope: This SOP is applicable for sampling and testing of sterile surgical gloves. Responsibility: Personnel (Microbiology-QC) shall be responsible for sampling and testing of sterile surgical gloves. Executive/ Officer shall be responsible for ensuring the compliance to the procedure. Head–Microbiology shall…

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Microbiology

Why disinfectant sterilization required in pharma injectable?

Posted on By Pharmaceutical Guidanace

Disinfection Disinfection is a process that is designed to kill actively growing and vegetative microbial microorganisms to a certain level, and it does not, unless the disinfectant is classified as a sterilant, apply to bacterial endospores. Disinfection a process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects and  reduces the…

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Microbiology

SOP on Fogging of Microbiology Testing Areas

Posted on By Pharmaceutical Guidanace

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. Responsibility: Chemist or above of Microbiology Laboratory: Head – Microbiology section. Accountability: Head – Quality Control. Procedure: Operation Perform the Fogging of Microbiology once in a week at the…

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Microbiology

Handling of Microbiological Data Deviation in Microbiology Laboratory

Posted on By Pharmaceutical Guidanace

Objective: To lay down the procedure for Handling of Microbiological Data Deviation in Microbiology Laboratory. Scope: This procedure is applicable to environmental monitoring excursions (namely Passive air sampling, Active air sampling, Surface sampling, Personnel monitoring, and Compressed gas monitoring)obtained during the Environmental monitoring, Sterility testing, Bacterial Endotoxin Test, Bioburden, Microbial Limit test, Liquid borne particulate…

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Microbiology

OOS in Microbiology

Posted on By Pharmaceutical Guidanace

OOS in Microbiology Out-of-specification (OOS) occurrences pertain to situations where microbiological test outcomes deviate from predetermined acceptance criteria or specifications. These occurrences can arise due to a variety of factors, spanning from technical complications to procedural mistakes. The identification and resolution of OOS events play a crucial role in upholding the dependability of microbiological data,…

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Microbiology

DISINFECTANT VALIDATION

Posted on By Pharmaceutical Guidanace

DISINFECTANT VALIDATION To evaluate the efficiency of disinfectants that are being used for the surface and area sanitization of controlled and critical clean rooms. The disinfectants when used as per the recommendations of the manufacturer for dilution and the contact time should be able to inhibit the growth of the test microorganisms. TABLE OF CONTENTS…

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Microbiology, Validation & Qualification

PROTOCOL TO EVALUATE EFFICACY OF UV GERMICIDAL LAMP WITH KNOWN MICROORGANISM

Posted on By Pharmaceutical Guidanace

PROTOCOL TO EVALUATE EFFICACY OF UV GERMICIDAL LAMP WITH KNOWN MICROORGANISM OBJECTIVE The objective of this study is to determine the efficacy of UV germicidal lamp of Laminar air flow and pass box with known microorganism. This ensures that the UV is effective enough to kill the microorganisms on exposure to a defined period and…

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Microbiology, Validation & Qualification

SOP for environmental  monitoring of air

Posted on By Pharmaceutical Guidanace

SOP for environmental  monitoring of air OBJECTIVE  :To lay down a procedure for environmental  monitoring of air. SCOPE  :This SOP shall provide the procedure for monitoring the viable air borne count . RESPONSIBILITY :Microbiologist ACCOUNTABILITY Manager QC/QA PROCEDURE  The microbial environmental conditions  shall be monitored as per defined frequency and sampling schedule  by active air…

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Microbiology

SOP on Procedure for viable air monitoring in pharmaceutical company

Posted on By Pharma Editor

SOP on Procedure for viable air monitoring in pharmaceutical company OBJECTIVE To lay down a procedure for environmental monitoring of air. SCOPE This SOP shall provide the procedure for monitoring the viable air borne count. RESPONSIBILITY Quality Control Executive / Officer. ACCOUNTABILITY Head Quality Assurance. PROCEDURE The microbial environmental conditions shall be monitored by Settle…

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Microbiology

SOP on Media Preparation

Posted on By Pharmaceutical Guidanace

SOP on Media Preparation Objective: To lay down the procedure for Preparation of Media. Scope: This SOP is applicable for preparation of sterile media used in Microbiology Laboratory of (Pharmaceutical Company Name). Responsibility: Microbiologist or above of Microbiology Laboratory. Head – Microbiology section. Accountability: Head – Quality Control Head – Quality Assurance. Abbreviations and Definitions…

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Microbiology

SOP on operation, cleaning and maintenance of the Stericheck system

Posted on By Pharmaceutical Guidanace

SOP on operation, cleaning and maintenance of the Steri-check system Objective: To lay down a procedure for operation, cleaning and maintenance of the Steri-check system. Scope: This SOP is applicable to Steri-check system present in the microbiology lab of (Pharmaceutical Company Name). Responsibility: Officer or above of Microbiology Laboratory: Head – Microbiology section / Nominee….

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Microbiology

SOP of Hot Air Oven

Posted on By Pharmaceutical Guidanace

SOP of Hot Air Oven Objective To lay down the procedure for Operation, Calibration, Cleaning and Maintenance of Hot Air Oven.  Scope This SOP is applicable for Operation, Calibration, Cleaning and Maintenance of Hot Air Oven in Microbiology Laboratory of (Pharmaceutical Company Name). Responsibility Officer or above of Microbiology Laboratory. Head – Microbiology section. Accountability…

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Microbiology

SOP of Vortex mixer

Posted on By Pharmaceutical Guidanace

SOP of Vortex mixer Objective To lay down the procedure for Operation and Cleaning of Vortex mixer  Scope This SOP is applicable for Operation and Cleaning of Vortex mixer in Microbiology Laboratory. (Pharmaceutical Company Name). Responsibility Microbiologist or above of Microbiology Laboratory. Head – Microbiology section / Nominee. Accountability Head – Quality Control. / Nominee….

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Microbiology

SOP of Media Decontamination and Disposal after used

Posted on By Pharmaceutical Guidanace

SOP of Media Decontamination and Disposal after used Objective To lay down the procedure for Decontamination and Disposal of Used Media  Scope This SOP is applicable for Decontamination and Disposal of Used Media. (Pharmaceutical Company Name). Responsibility Microbiologist or above of Microbiology Laboratory. Head – Microbiology section / Nominee. Accountability Head – Quality Control. /…

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Microbiology

SOP of LAL Reagent

Posted on By Pharmaceutical Guidanace

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 – Quality Control I Nominee….

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Microbiology

SOP of Temperature Monitoring of Microbiology Equipments

Posted on By Pharmaceutical Guidanace

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. Head – Microbiology section /…

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Microbiology

SOP of Total Viable Spore Count Test for Biological Indicators

Posted on By Pharmaceutical Guidanace

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 Chemist or above of QC…

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Microbiology