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Amtronix Technologies Interview Questions and Answers
Q1. What is Disintegration test? What is the DT time for enteric coated tablets? What is the liquid medium used for enteric coated tablets?
Disintegration test is a test to determine the time it takes for a tablet to break down into smaller particles. DT time for enteric coated tablets is typically 1-2 hours. The liquid medium used for enteric coated tablets is usually 0.1 N HCl or simulated gastric fluid.
Disintegration test determines the time it takes for a tablet to disintegrate into smaller particles
DT time for enteric coated tablets is usually 1-2 hours
Liquid medium used for enteric coated tablets can be 0.1...read more
Q2. What is In Process Quality Control. What are the tests carried out.
In Process Quality Control involves testing and monitoring products during various stages of production to ensure quality standards are met.
Testing and monitoring products during production
Identifying and addressing any deviations from quality standards
Ensuring consistency and reliability of products
Examples: visual inspection, dimensional measurements, chemical analysis
Q3. What are all the major drug regulatory authorities of the world? What are the 21 CFR guidelines?
Major drug regulatory authorities include FDA, EMA, PMDA, Health Canada, TGA, etc. 21 CFR guidelines are regulations set by the FDA for pharmaceutical industry.
Major drug regulatory authorities include FDA (United States), EMA (European Union), PMDA (Japan), Health Canada, TGA (Australia), etc.
21 CFR guidelines are regulations set by the FDA under Title 21 of the Code of Federal Regulations.
21 CFR Part 210 and 211 cover Good Manufacturing Practices (GMP) for pharmaceutical pr...read more
Q4. What is friability test ? Why it is carried out?
Friability test is a test to measure the tendency of a tablet to chip, crumble, or break under mechanical stress.
Friability test is carried out to assess the durability of tablets during handling, packaging, and transportation.
It involves placing a sample of tablets in a drum and rotating it for a specified time to simulate mechanical stress.
The tablets are then weighed before and after the test to determine the percentage of weight loss, which indicates friability.
The test h...read more
Q5. What is HVAC? Importance of it?
HVAC stands for Heating, Ventilation, and Air Conditioning. It is important for maintaining comfortable indoor temperatures and air quality.
HVAC systems control temperature, humidity, and air quality in buildings.
Heating systems provide warmth during cold weather.
Ventilation systems circulate fresh air and remove stale air.
Air conditioning systems cool and dehumidify indoor air.
Properly functioning HVAC systems are essential for occupant comfort and health.
Regular maintenance...read more
Q6. What is a Data logger?
A data logger is a device that records data over time for monitoring and analysis purposes.
Data loggers are used to measure and record parameters such as temperature, humidity, pressure, and light levels.
They are commonly used in industries like agriculture, food storage, transportation, and environmental monitoring.
Data loggers can be standalone devices or integrated into larger systems for data collection and analysis.
Examples of data loggers include temperature loggers use...read more
Q7. Calibration of all instruments
Calibration ensures that instruments provide accurate and reliable measurements, essential for quality assurance.
Calibration is the process of adjusting instruments to meet specified standards.
Regular calibration helps maintain accuracy and compliance with regulations.
For example, a thermometer used in a lab must be calibrated to ensure it reads temperatures accurately.
Calibration intervals depend on the instrument type and usage frequency.
Documentation of calibration results...read more
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