1.

General Quality Assurance Knowledge

Q1: Can you briefly introduce yourself and your experience in the pharmaceutical industry?

Answer:
"I hold a B.Pharmacy degree from DBIT Dehradun (2015-2019) and have 2.5+ years of experience as an IPQA personnel at J.K. Prints &
Pack (Pharma Division). Currently, I am working at HAB Pharmaceutical Research Ltd., Dehradun, handling APQR, SOPs preparation,
issuance, Change Control, Deviations, and Incidents. I am also skilled in SAP B1, Microsoft Excel, and Tally Prime, which help me in data
analysis and documentation processes."

Q2: What do you understand by Good Manufacturing Practices (GMP)? Why is it essential in pharma?

Answer:
"GMP refers to the guidelines and regulations that ensure pharmaceutical products are consistently produced and controlled according to
quality standards. It covers all aspects of production, from raw materials to finished products. GMP is essential to:
✔ Ensure product safety, efficacy, and quality
✔ Minimize risks of contamination, mix-ups, and errors
✔ Ensure regulatory compliance with bodies like WHO, USFDA, and EU GMP."

Q3: What are the key quality assurance activities in a pharmaceutical company?

Answer:
✔ Change Control Management
✔ Deviation and Incident Handling
✔ SOP Preparation & Review
✔ Batch Record Review

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✔ APQR (Annual Product Quality Review)
✔ Regulatory Compliance & Documentation

2. Change Control
Q4: What is Change Control, and why is it important in pharma?

Answer:
"Change Control is a formal system used to manage planned and unplanned changes in the pharmaceutical industry. It ensures that any
change does not negatively impact the quality, safety, or efficacy of the product. It is crucial to:
✔ Maintain regulatory compliance
✔ Ensure product consistency
✔ Prevent unexpected failures after implementation of changes."

Q5: Can you explain the Change Control process?

Answer:
The Change Control process includes:

1. Initiation: Identifying and documenting the proposed change

2. Impact Assessment: Evaluating the impact on product, process, and compliance
3. Review & Approval: Quality Assurance (QA) and regulatory teams approve/reject the change
4. Implementation: Making changes with proper monitoring
5. Verification: Ensuring the change is effective without negative impact
6. Closure: Final documentation and regulatory submission (if required)

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Q6: What are the different types of Change Controls?

Answer:
✔ Planned Changes: Equipment upgrades, facility modifications, process improvements
✔ Unplanned Changes: Emergency repairs, sudden supplier changes
✔ Regulatory Changes: Compliance with new guidelines

Q7: What documents are required for Change Control initiation?

Answer:
✔ Change Control Form (CCF)
✔ Risk Assessment Report
✔ Impact Assessment Report
✔ Updated SOPs (if applicable)
✔ Regulatory Compliance Review

Q8: How do you assess the impact of a change?

Answer:
"We perform risk assessments by evaluating:
✔ Impact on product quality, stability, and safety
✔ Effect on regulatory compliance
✔ Possible interdepartmental effects (e.g., QC, production, validation)"

Q9: What is the difference between Planned and Unplanned Change?

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Answer:
✔ Planned Change – Foreseen and documented before implementation (e.g., equipment upgrade).
✔ Unplanned Change – Sudden and requires immediate approval (e.g., breakdown requiring urgent replacement).

3. Incident Management
Q10: What is an Incident in the pharmaceutical industry?

Answer:
"An Incident is any unexpected event during production that may or may not affect the quality, safety, or efficacy of the product. Examples
include power failure, machine breakdown, mix-ups, or accidental contamination."

Q11: How do you differentiate between an Incident and a Deviation?

Answer:
✔ Incident: Unplanned event without immediate impact on product quality (e.g., machine failure).
✔ Deviation: Non-compliance with SOPs that may directly impact product quality (e.g., incorrect temperature setting during storage).

Q12: How do you investigate an Incident?

Answer:
✔ Identify the root cause (using 5 Whys or Fishbone Diagram)
✔ Assess impact on product quality
✔ Implement corrective & preventive actions (CAPA)
✔ Document & report findings

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4. Deviations
Q13: What is a Deviation?

Answer:
"A Deviation occurs when a process does not follow established SOPs, BMR/BPR, or GMP guidelines. It can be planned (e.g., temporary
process changes) or unplanned (e.g., procedural error, equipment malfunction)."

Q14: How do you classify Deviations?

Answer:
✔ Minor: No impact on quality (e.g., documentation errors)
✔ Major: Potential quality impact (e.g., incorrect raw material weighing)
✔ Critical: Directly affects product safety & efficacy (e.g., microbial contamination in sterile area)

Q15: How do you perform a Deviation Investigation?

Answer:
✔ Identify the event details
✔ Perform root cause analysis
✔ Evaluate product impact
✔ Implement CAPA
✔ Document findings and report to QA/QC

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Q16: Can you share an example of a Deviation you investigated?

Answer:
"In my current role, we detected a temperature deviation in the storage area. After investigation, we found that an employee had incorrectly
set the temperature control. We implemented CAPA by:
✔ Retraining staff
✔ Enhancing SOP clarity
✔ Installing an automated temperature monitoring system"

5. Case-Based Questions
Q17: What would you do if an unapproved change was implemented?

Answer:
✔ Immediately report the issue
✔ Assess the impact on product quality
✔ Initiate a Deviation Report
✔ Ensure CAPA to prevent recurrence

Q18: How do you handle recurring equipment failures leading to Incidents?

Answer:
✔ Conduct trend analysis to identify root cause
✔ Implement preventive maintenance schedules
✔ Upgrade or replace faulty equipment

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6. Regulatory & Compliance
Q19: What are the regulatory guidelines related to Change Control, Incidents, and Deviations?

Answer:
✔ WHO GMP – Change Control & risk-based approach
✔ USFDA 21 CFR Part 211 – Documentation & Deviation reporting
✔ EU GMP Chapter 1 – Quality Management principles

Q20: How do you prepare documentation for regulatory audits?

Answer:
✔ Maintain Change Control logs, Incident records, and Deviation reports
✔ Ensure traceability & justification of changes
✔ Provide CAPA documentation for each non-conformance

Final Question: Why should we hire you?

Answer:
"I bring hands-on experience in Change Control, Incident & Deviation handling with strong regulatory knowledge. My analytical mindset,
attention to detail, and compliance expertise make me a strong candidate for this role."

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