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Microbiology

Sampling and testing of Sterile surgical Gloves

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 …

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Procedure for Microbiological Monitoring of Purified water

Pharmaceutical GuidanaceMr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco …

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Why disinfectant sterilization required in pharma injectable?

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 …

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SOP on 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. Responsibility: Chemist or above of Microbiology Laboratory: Head – Microbiology section. Accountability: Head – Quality Control. Procedure: Operation Perform the Fogging of Microbiology once …

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Handling of Microbiological Data Deviation in Microbiology Laboratory

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 …

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SOP on OOS in microbiology

Objective: To lay down the procedure for investigation of out of specification of test results in Microbiology Laboratory. Scope: This Scope is limited to out of specification results of microbial testing, sterility testing and environmental testing in microbiology section of Formulation plant. Responsibility: Head Microbiology Head Quality Control Accountability: Head-Q.A …

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DISINFECTANT VALIDATION

DISINFECTANT VALIDATION TABLE OF CONTENTS  Section No Topics Page No 1.0 Protocol Approval 2.0 Objective 3.0 Acceptance Criteria 4.0 Responsibilities 5.0 Validation Methodologies 6.0 Evaluation of test Result 7.0 Re-validation Frequency 8.0 Documentation 9.0 Conclusion PROTOCOL APPROVAL   Name /  Designation  Signature  Date  Prepared By Microbiologist      Checked By  Microbiology …

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PROTOCOL TO EVALUATE EFFICACY OF UV GERMICIDAL LAMP WITH KNOWN MICROORGANISM

PROTOCOL TO EVALUATE EFFICACY OF UV GERMICIDAL LAMP WITH KNOWN MICROORGANISM INDEX PART –I                                                                                                 Page no. Objective Brief Description Purpose Procedure Acceptance criteria PART –II Data generation for viable count PART –III Summary Recommendation Attachments PART-I  1.0          OBJECTIVE The objective of this study is to determine the efficacy of  …

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SOP for environmental  monitoring of air

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 …

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SOP on Procedure for viable air monitoring in pharmaceutical company

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 …

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