Microbiology

SOP For Microbial Monitoring in Drain Point of Pharmaceutical Manufacturing sites.

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  SOP For Microbial Monitoring in Drain Point of Pharmaceutical Manufacturing sites. PROCEDURE: Carryout the microbiological testing of the drain as per procedure mentioned below. Prepare the swab sticks. After sterilization mark the swab sticks with location I.D. and date of sampling. Take the swabs at the respective area and withdraw the sample from critical […]

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Most Common Interview Questions For Regulatory Affairs Department.

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Most Common Interview Questions For Regulatory Affairs Department.   1.What is Regulatory Affairs? Ans-Regulatory Affairs in a Pharmaceutical industry, is a profession which acts as the interface between the pharmaceutical industry and Drug Regulatory authorities across the world. It is mainly involved in the registration of the drug products in respective countries prior to their

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How to Investigate Out Of Specification(OOS) Test Results….???( USFDA Phase -I)

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How to Investigate Out Of Specification(OOS) Test Results….??? ( USFDA Phase -I) Out Of Specification(OOS) :-  The all test results which goes outside the specification or acceptance criteria established in Drug Dossiers, Drug Master files, Its official Pharmacopeias, Or the manufacturer comes Under Out of Specification(OOS).   What USFDA guideline says about Investigation of Out

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SOP on Maintenance and Preparation of Anaerobic Culture Suspension.

Microbiology

SOP on Maintenance and Preparation of Anaerobic Culture Suspension ( Clostridium Sporogenes ). This procedure is for Maintenance & preparation of culture suspension for anaerobic microorganisms in Microbiology Department.  it includes maintenance of culture & preparation of culture suspension as per Culture Dilution Method. PROCEDURE: Maintenance: Prepare Nutrient Agar as per Media preparation SOP Pour 5 mL

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Microbiology

Microbiology

Microbiology Microbiology is the crucial section of Sterile Pharmaceutical products, it is very Important in Non- Sterile Products. Microbiology section is divided in following sections;  Antimicrobial Effectiveness Testing.(USP <51>)(Ph. Eur. general texts 5.1.3)  Microbial Examination of Non-Sterile Products.( USP <61>,<62>)(Ph. Eur. method 2.6.13./2.6.12) Sterility Testing.(USP <71>),(Ph. Eur. method 2.6.1) Bacterial Endotoxin Testing.( USP <85>) Particulate

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