10+ Adroit Infoways Interview Questions and Answers

The stationary phase used in HPLC can be either polar or non-polar.

• Polar stationary phases are used for separating polar compounds, while non-polar stationary phases are used for separating non-polar compounds.

• Common polar stationary phases include silica gel and alumina, while common non-polar stationary phases include C18 and C8.

• The choice of stationary phase depends on the properties of the sample being analyzed and the desired separation.

• The stationary phase is typically ...read more

A swab sample involves using a swab to collect a sample from a specific area, while a rinse sample involves rinsing a larger area to collect a sample.

• Swab sample: Collects a sample from a specific area using a swab.

• Rinse sample: Involves rinsing a larger area to collect a sample.

• Swab samples are commonly used for surface testing, such as swabbing a countertop or equipment.

• Rinse samples are often used for environmental testing, such as rinsing a large area of a production floo...read more

I have handled various instruments including calipers, micrometers, gauges, and spectrophotometers.

• Calipers for measuring distance between two opposite sides of an object

• Micrometers for measuring small distances with high precision

• Gauges for measuring various parameters such as pressure, temperature, and humidity

• Spectrophotometers for measuring the intensity of light in a spectrum

• Also familiar with pH meters, balances, and pipettes

• Regularly trained on new instruments and thei...read more

HPLC stands for High Performance Liquid Chromatography. It is a technique used to separate, identify, and quantify components in a mixture.

• HPLC works on the principle of separation of components based on their interaction with the stationary phase and mobile phase.

• The stationary phase is a solid or liquid material that is packed into a column, while the mobile phase is a liquid that flows through the column.

• The sample is injected into the mobile phase and as it flows through ...read more

Criteria for Uniformity of Dosage Unit

• Uniformity of weight and drug content in each dosage unit

• Acceptable range of variation in weight and drug content

• Ensuring consistent potency and efficacy of the drug

• Testing methods include weight variation test and content uniformity test

• Criteria varies depending on the type of drug and dosage form

Dissolution criteria refers to the amount of drug substance that should dissolve in a specified time period.

• It is a measure of drug release from a dosage form.

• It is important for ensuring the drug is being absorbed properly.

• The criteria varies depending on the type of drug and dosage form.

• For example, immediate-release tablets should dissolve at least 80% in 30 minutes.

• Slow-release tablets may have a longer dissolution time.

I have performed the microbiological test the most.

• Microbiological test is crucial in ensuring the safety and quality of products.

• Examples include testing for microbial contamination in food and pharmaceutical products.

• I have performed this test numerous times in my previous roles as a Quality Control Officer.

ALCOA and ALCOA+ are guidelines for data integrity in pharmaceutical industry.

• ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate.

• ALCOA+ adds the principles of Complete, Consistent, Enduring, and Available.

• These guidelines ensure that data is reliable, accurate, and can be traced back to its source.

• For example, all data entries must be dated and signed by the person who made them.

• ALCOA+ also requires that data is complete and consistent throughout ...read more

Stages of process validation include process design, process qualification, and continued process verification.

• Process design involves defining the process parameters and identifying critical process parameters.

• Process qualification involves testing the process to ensure it consistently produces quality products.

• Continued process verification involves monitoring the process to ensure it remains in a state of control.

• Examples of process validation include sterilization process...read more

OOS stands for Out of Specification.

• OOS refers to a result that falls outside the predetermined acceptance criteria or specification limits.

• It can occur during testing, manufacturing, or packaging processes.

• OOS results must be investigated to determine the root cause and appropriate corrective actions.

• Examples include a product failing a potency test or a package not meeting weight requirements.

Criteria for blend uniformity in pharmaceutical manufacturing

• Blend uniformity is the degree to which the API and excipients are evenly distributed throughout the blend

• Criteria for blend uniformity include acceptance criteria for assay and content uniformity

• Sampling plan and testing method should be appropriate for the blend characteristics

• Blend uniformity testing should be performed at appropriate stages of manufacturing process

• Examples of blend uniformity tests include strat...read more

System suitability parameters are used to ensure that the HPLC system is working properly.

• System suitability parameters include resolution, tailing factor, and peak symmetry.

• These parameters are measured using a standard sample before running actual samples.

• Acceptance criteria for each parameter should be established and documented.

• If the system fails to meet the acceptance criteria, corrective action should be taken before running samples.

• Examples of corrective action includ...read more

Process validation is the documented evidence that a process is capable of consistently producing a product that meets its predetermined specifications and quality attributes.

• Process validation is a critical component of quality assurance in manufacturing.

• It involves establishing documented evidence that a process is capable of consistently producing a product that meets its predetermined specifications and quality attributes.

• Process validation typically involves three stages...read more

OOT stands for Out of Trend. It is a term used in quality control to describe a result that falls outside of the expected range.

• OOT is a deviation from the expected trend or pattern

• It can be caused by various factors such as equipment malfunction, human error, or environmental changes

• OOT results should be investigated to determine the root cause and corrective actions taken

• Examples of OOT include a sudden spike or drop in test results, or a consistent shift in results over ti...read more

AV value in CU test is calculated by dividing the average of the duplicate readings by the standard solution value.

• AV value stands for Average Value.

• CU test is a test used to determine the copper content in a sample.

• Duplicate readings are taken to ensure accuracy.

• The standard solution value is a known concentration of copper used as a reference.

• AV value = (Average of duplicate readings) / (Standard solution value)

Cleaning validation is the process of ensuring that equipment and surfaces are properly cleaned to prevent contamination.

• Cleaning validation is a critical part of ensuring product quality and safety.

• It involves testing and verifying that cleaning procedures are effective and consistent.

• This can include swabbing surfaces and equipment to test for residual contaminants.

• Cleaning validation is required in industries such as pharmaceuticals, food and beverage, and medical devices....read more