Pharma Interview Q and A Sep-13-21

September 13, 2021: Pharmaceutical Interview Questions and Answers

#Microscope #PharmacopoeialChaptersForMicrobiology

1. Explain the parts of compound light microscopes used in the pharmaceutical microbiology laboratory?

Compound light microscopes - pharmaceutical microbiology

Illuminator: Light source at the base of the microscope enable better view of object;

Condensor: This is a two lens system that collects and concentrates light from the illuminator and directs it to the iris diaphragm;

Iris diaphragm: regulates the amount of light entering the lens system;

Stage: This is a platform for the slide with hole in the center to let light from the illuminator pass through. It consists of clips to hold the slide lace;

Eye pieces: To view object;

Objectives: To magnify the object as per rating on it

2. What are the pharmacopoeial chapter and sections applicable for microbiology?

Pharmacopoeial chapter(s)Use
Microbiological examination of nonsterile products: total viable aerobic count (Ph. Eur. 2.6.12, USP <61>)   USP <2021> Microbial enumeration tests-nutritional and dietary supplements   USP <2023> Microbiological attributes of nonsterile nutritional and dietary supplementsOrganism count in raw materials, water, finished products
Microbiological examination of nonsterile products: tests for specified organisms (Ph. Eur. 2.6.13, USP <62>)   USP <2022> Microbiological procedures for absence of specified microorganismsnutritional and dietary supplementsType of organisms present in raw materials, water, finished products
Ph. Eur. 5.1.4 Microbiological quality of pharmaceutical preparations/USP <1111> Microbiological attributes of nonsterile pharmaceutical productsDetermining limits and control factors
Sterility (Ph. Eur. 2.6.1, USP <71>) Pyrogens/endotoxin Rabbit Pyrogen Test (Ph. Eur. 2.6.8, USP<151>) Limulus amoebocyte lysate (LAL) bacterial endotoxin test (Ph. Eur. 2.6.14, USP<85>)Sterility test for finished products endotoxin test for raw materials, pharmaceuticals waters, finished products
Antimicrobial preservative efficacy testing (Ph. Eur. 5.1.3, USP <51>)Antimicrobial preservative efficacy
Microbiological assay of antibiotics (E.P 2.7.2., USP<81>)Assays of antibiotic
USP <1112> Application of water activity determination to nonsterile pharmaceutical productsWater activity can be used to predict microbial proliferation in the product
USP <1211> Sterilization and sterility assurance of compendial articles. There are a series of subchapters that describe specific sterilization methodsSterilization and microbial reduction
USP <55> Biological indicatorsBiological indicators for assessing microbial reduction
USP <1113> Microbial characterization, identification, and strain typingMicrobial identification
USP <1117> Microbiological best laboratory practiceManagement of microbiological good laboratory practice
USP <1116> Microbiological control and monitoring of aseptic processing environmentsEnvironmental monitoring for aseptic environments
Ph. Eur. 5.1.6 Alternative methods for control of microbiological quality/ USP <1223> Validation of alternative microbiological methodsAlternative methods/ Rapid microbiological methods
USP <1115> Bioburden control of nonsterile drug productsBioburden control
USP <1227> Validation of microbial recovery from pharmacopeial articlesMicrobial method validation

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