Microbiology

Most Common Interview Questions For Regulatory Affairs Department.

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)

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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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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