FDC Quality Control Officer Interview Questions and Answers

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.

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...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 b...read more

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.

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 ...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 att...read more

HPLC troubleshooting involves identifying and resolving issues with the equipment or method.

• Check for air bubbles in the system

• Verify column temperature and mobile phase composition

• Inspect the detector and ensure proper calibration

• Review sample preparation and injection volume

• Consult instrument manual or technical support for further assistance

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)