This article will help you prepare for the quality assurance interview if you are a fresher or experienced looking for a job opportunity, these interview questions will help you.

Quality Assurance Interview Questions  

What is the difference between validation and calibration?

• Validation provides documented evidence that a specific method or process consistently produces a product that meets predetermined requirements and quality attributes. Validation is done by preparing a validation protocol.
• Calibration ensures that equipment produces values within specified limits. This is done  by comparing the calibrated values with the standard. Calibration is conducted according to the calibration SOP. Calibration is done daily and trimonthly in case of balances.

What is 21 CFR Part 11?

Title 21 CFR Part 11 of the Code of Federal Regulations establishes the Food and Drug Administration (FDA) provides guidelines on electronic records and electronic signatures. This guideline highlights that electronic signatures are equivalent to handwritten signatures.

What is an audit trail?

•  An audit trail is a secure, computer-generated, time-stamped record that allows the reconstruction of events related to the creation, modification, or deletion of an electronic record, and the main function of audit trail is to ensure data integrity as it can track all the changes made to the electronic records and can help detect any unauthorized or accidental alterations of data.

Tell me Why stability studies are conducted?

Stability studies are important aspect of pharmaceutical development, which aims to ensure the drug substance or drug product retains its intended quality, safety and efficacy throughout the shelf life.

In simple stability studies are conducted for the following reasons

• To find the degradation pathways
• To ensure patient safety
• To determine the shelf life
• To determine storage conditions
• To gather data for product development.

What are the types of stability studies?

Stability studies are of 3 types which include

• Long term stability studies
• Accelerated stability studies
• Intermediate stability studies

What is the duration of long term and accelerated stability studies?

The duration of long-term stability studies is 12 months minimum, and ca be extended based on the Whereas the duration of accelerated stability studies is six months.

• Storage conditions for long term stability studies 25°C ± 2°C with 60% ± 5% relative humidity (RH).
• For accelerated stability studies 40°C ± 2°C with 75% ± 5% RH