QA Interview Questions | Quality Assurance Job Questions | 40+ QA Questions & Answers

Summary

This video provides an extensive guide for individuals preparing for Quality Assurance (QA) interviews in the pharmaceutical industry. It covers over 40 commonly asked interview questions, providing clear answers on key topics such as GMP, cGMP, validation, root cause analysis (RCA), line clearance, documentation, and change control. Additionally, the video explains in-process checks for various dosage forms, official and non-official tests, dissolution testing, friability, and quality control measures for different pharmaceutical products. By following this video, candidates will be well-equipped to answer questions and understand essential concepts in pharmaceutical QA roles.

Takeaways

• 😀 GMP (Good Manufacturing Practice) ensures products are manufactured according to strict quality standards and are safe for human use.
• 😀 CGMP (Current Good Manufacturing Practice) emphasizes the use of current standards and systems for high-quality product manufacturing.
• 😀 Validation provides documented evidence that a process or method will consistently meet predefined specifications and quality standards.
• 😀 Root Cause Analysis (RCA) is a data-driven approach used to identify the main reason for a problem and its solution in pharmaceutical manufacturing.
• 😀 Line clearance is the process of ensuring that equipment, areas, and lines are free from residues from previous products before starting new manufacturing processes.
• 😀 Documentation in pharmaceutical industries includes written materials like SOPs, work instructions, and procedures that ensure compliance with regulations.
• 😀 SOP (Standard Operating Procedure) outlines how specific tasks or activities should be performed, ensuring consistency and compliance.
• 😀 Change Control is a system used to document and manage changes to existing processes, equipment, or facilities, ensuring proper risk assessment.
• 😀 In-Process Checks (IPC) are quality control measures performed during manufacturing to ensure that products meet required specifications.
• 😀 ISO classification for cleanrooms in pharmaceutical manufacturing ranges from ISO Class 5 (the cleanest) to ISO Class 8 (the least clean), each used for specific operations.
• 😀 Friability testing measures the durability of tablets, with an acceptance criterion of no more than 1% weight loss after the test.

Q & A

What is GMP?

GMP stands for Good Manufacturing Practices. It is a set of guidelines provided by the US FDA that ensures products are manufactured according to quality standards, are free from contamination, and are fit for human use.

What is the difference between GMP and CGMP?

GMP refers to Good Manufacturing Practices, while CGMP refers to Current Good Manufacturing Practices. CGMP ensures the use of current standards and systems to provide high-quality products by designing, controlling, and monitoring manufacturing processes and facilities.

What is the purpose of validation in the pharmaceutical industry?

Validation is the documented evidence that provides a high level of assurance that a specific process or method will consistently produce the required level of results with predefined specifications and quality.

What are the types of validation?

The four types of validation are prospective validation, concurrent validation, retrospective validation, and revalidation. Each serves a different purpose in ensuring processes meet required standards.

What is RCA and which tools are used for root cause analysis?

RCA stands for Root Cause Analysis, which is a method used to identify the main reason for a specific problem in the pharmaceutical industry. Tools used for RCA include the 5 Whys, Fishbone Diagram, Failure Mode and Effects Analysis (FMEA), Pareto Chart, and Scatter Diagram.

What is line clearance and why is it important?

Line clearance is the process of ensuring that the area, line, or equipment is free from residues and previous product traces before starting new dispensing, manufacturing, or packaging activities. It is important for preventing cross-contamination and ensuring the integrity of the new product.

What is the significance of documentation in pharmaceutical industries?

Documentation in pharmaceutical industries refers to written materials such as SOPs, work instructions, and records that ensure processes are followed correctly, maintain data integrity, and comply with regulatory requirements.

What is the difference between type A, type B, and type C cleaning?

Type A cleaning refers to major cleaning, type B cleaning refers to minor cleaning, and type C cleaning refers to shift cleaning. These types categorize the level of cleaning required in different situations in pharmaceutical manufacturing.

Why is Change Control required for new equipment or areas?

Change Control is a system used to manage and regulate changes in existing systems, equipment, or procedures. It is also required when introducing new equipment or areas to ensure that all changes are properly documented and controlled.

What are in-process checks (IPC) and how do they differ across dosage forms?

In-process checks are tests performed during manufacturing to ensure that standards are met throughout the process. IPCs differ depending on the dosage form. For example, for tablets, hardness and weight variation are checked, while for liquid dosage forms, volume and pH are monitored.