Question 1

What is GMP? Why is it important in the pharmaceutical industry?

Accepted Answer

Best Answer:
GMP stands for Good Manufacturing Practices. It is a set of guidelines that ensure pharmaceutical products are consistently produced and controlled according to quality standards. GMP covers all aspects of production – from raw materials, premises, and equipment to training and hygiene of staff. It minimizes risks involved in pharmaceutical production that cannot be eliminated through testing the final product.
How to Answer:
Stick to the definition first, then explain its purpose and importance in a few simple sentences. Always highlight product safety and patient health.

Question 2

What is the difference between GMP and cGMP?

Accepted Answer

Best Answer:
GMP refers to the basic principles of good manufacturing practice. cGMP stands for “current” Good Manufacturing Practices, which emphasizes the need for companies to use up-to-date technologies, systems, and processes to comply with quality standards. The ‘c’ ensures that the practices are continuously improved and not outdated.
How to Answer:
Emphasize the word “current” and explain that regulations evolve. Use an example if possible (e.g., updating documentation practices from paper to digital).

Question 3

What are the key principles of GMP?

Accepted Answer

Best Answer:
Defined procedures and instructions to ensure consistency.
Documentation of all processes and activities.
Qualified personnel and proper training.
Quality control at every stage of production.
Proper facilities and equipment.
Regular audits and inspections.
Batch traceability and recall systems.
How to Answer:
List a few key principles and link them to ensuring product quality and patient safety. If asked for more, be ready to elaborate.

Question 4

What do you understand by the term 'Quality by Design'?

Accepted Answer

Best Answer:
Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and control. It involves designing quality into the product from the beginning, rather than testing for it at the end.
How to Answer:
Mention that QbD is part of modern GMP practices. Explain that it helps build quality into the process rather than relying only on final product testing.

Question 5

Can you name some major global GMP regulatory bodies?

Accepted Answer

Best Answer:
Yes, some major regulatory bodies are:
US FDA (Food and Drug Administration)
WHO (World Health Organization)
EMA (European Medicines Agency)
MHRA (Medicines and Healthcare Products Regulatory Agency – UK)
TGA (Therapeutic Goods Administration – Australia)
CDSCO (Central Drugs Standard Control Organization – India)
How to Answer:
List at least 3–5 key bodies. If the job is local, include national authority (like CDSCO). If applying for export-oriented companies, highlight global ones.

Question 6

What is Schedule M in the pharmaceutical industry?

Accepted Answer

Best Answer:
Schedule M is part of the Drugs and Cosmetics Act in India. It lays down the GMP requirements for manufacturing units of pharmaceutical products, including guidelines on premises, equipment, personnel, sanitation, documentation, and quality control.
How to Answer:
Define it and highlight that it is the regulatory backbone for GMP compliance in the Indian pharma sector.

Question 7

What is the role of the QA department in GMP compliance?

Accepted Answer

Best Answer:
The QA department is responsible for ensuring that all manufacturing and testing activities comply with GMP guidelines. QA prepares and reviews SOPs, audits processes, ensures documentation accuracy, approves raw materials and finished products, handles deviations, and oversees validations and training.
How to Answer:
Describe QA’s role as the guardian of compliance and quality gatekeeper. Show you understand QA’s cross-functional involvement.

Question 8

What is the role of self-inspection in GMP?

Accepted Answer

Best Answer:
Self-inspection is a systematic and independent examination of all production and quality control processes by the company’s own team. It helps identify gaps, non-conformances, and areas for improvement before external audits. It is a preventive tool to maintain GMP compliance.
How to Answer:
Mention that it ensures continuous compliance and helps the organization be audit-ready at all times.

Question 9

What are some common GMP violations observed during audits?

Accepted Answer

Best Answer:
Incomplete or missing documentation
Poor sanitation or hygiene
Unqualified personnel
Lack of validation or calibration records
Data integrity issues
Deviations not recorded or addressed
Improper storage or labeling
How to Answer:
Mention 3–4 major ones with emphasis on documentation, personnel qualification, and data integrity.

Question 10

What are the consequences of GMP non-compliance?

Accepted Answer

Best Answer:
Consequences include:
Regulatory warnings (like Form 483, Warning Letter)
Product recalls
Production shutdown
Loss of product license
Legal penalties
Damage to company reputation
How to Answer:
Link the answer to patient safety, regulatory risk, and company reputation. Show you understand the high-stakes nature of GMP compliance.

Question 11

What is an SOP and why is it important in pharma?

Accepted Answer

Best Answer:
An SOP (Standard Operating Procedure) is a written document that provides step-by-step instructions for performing specific operations or activities consistently and correctly. In the pharmaceutical industry, SOPs are critical to ensure regulatory compliance, uniformity, reproducibility, and quality in all processes.
How to Answer:
Start by defining SOP, then explain that it ensures consistency and compliance. Emphasize that following SOPs reduces human error and is a key part of GMP adherence.

Question 12

What is the difference between a BMR and BPR?

Accepted Answer

Best Answer:
BMR stands for Batch Manufacturing Record. It contains detailed instructions and records of how a specific batch of a product was manufactured.
BPR stands for Batch Packaging Record. It contains details of how that same batch was packaged, labeled, and prepared for distribution.
How to Answer:
Mention that both documents ensure traceability and documentation of batch history but focus on different stages of the product lifecycle.

Question 13

What do you understand by GDP (Good Documentation Practice)?

Accepted Answer

Best Answer:
GDP refers to practices for creating, handling, and maintaining documents and records that are accurate, legible, traceable, and compliant with regulatory standards. It includes rules such as writing entries in permanent ink, not leaving blank spaces, recording data in real-time, and correcting errors with proper justification.
How to Answer:
Stress data integrity and real-time recording. Interviewers want to hear that you understand the importance of error-free, transparent documentation.

Question 14

What information should an SOP include?

Accepted Answer

Best Answer:
A well-prepared SOP should include:
Title
SOP number and version
Purpose or objective
Scope
Responsibility
Materials required (if any)
Procedure (step-by-step)
References
Revision history
Approval with signatures
How to Answer:
You don’t have to recite every point but highlight structure, clarity, and traceability. Focus on the step-by-step procedure and approval section.

Question 15

What is the review and approval process for SOPs?

Accepted Answer

Best Answer:
SOPs are usually prepared by the department involved, reviewed by the Quality Assurance department, and then approved by the head of QA or an authorized official. The document is then assigned a control number and made available for use after proper training.
How to Answer:
Explain that the review ensures technical accuracy and approval ensures compliance and authorization. Always mention QA’s role in the approval process.

Question 16

How do you handle a situation where an SOP is not followed?

Accepted Answer

Best Answer:
If an SOP is not followed, a deviation must be recorded immediately. The incident should be investigated to identify the root cause, assess the impact, and implement corrective and preventive actions. Based on the outcome, the SOP may also be revised if found inadequate.
How to Answer:
This is a scenario-based question. Highlight immediate documentation, root cause analysis, and CAPA initiation. Emphasize compliance and transparency.

Question 17

What is a controlled document?

Accepted Answer

Best Answer:
A controlled document is a document that is officially approved, issued, tracked, and updated under a document control system. These include SOPs, specifications, protocols, and records that affect the quality of the product or process.
How to Answer:
Explain that controlled documents are version-controlled and changes require formal approval to avoid unauthorized use of outdated procedures.

Question 18

What is a logbook and how is it maintained in the QA department?

Accepted Answer

Best Answer:
A logbook is a record maintained to document usage, cleaning, calibration, or any event related to equipment or areas. In QA, logbooks are used for recording inspections, audit notes, document issuance, etc. Entries are made in indelible ink, dated, signed, and free from overwriting. Corrections are done with a single line and initialed.
How to Answer:
Mention key principles like real-time entry, legibility, no blank spaces, and controlled issuance.

Question 19

How often are SOPs reviewed or revised?

Accepted Answer

Best Answer:
SOPs are generally reviewed periodically, typically every 1 to 2 years, or earlier if there’s a change in process, regulatory requirement, or a deviation suggesting the SOP needs updating. Reviews ensure that SOPs remain accurate and compliant.
How to Answer:
Highlight periodic review cycles and the importance of keeping documents up to date with current practices.

Question 20

What is document version control and why is it necessary?

Accepted Answer

Best Answer:
Version control ensures that only the most current and approved version of a document is in use. Each revision is assigned a new version number, with older versions archived and marked obsolete. It prevents errors from using outdated information and maintains consistency across operations.
How to Answer:
Focus on the idea of traceability, consistency, and compliance. Employers want to know you understand the risk of using outdated procedures.

Question 21

What is a Master Formula Record (MFR)?

Accepted Answer

Best Answer:
An MFR is an official document that contains the master instructions for manufacturing a product batch. It includes specifications for raw materials, quantities, equipment, steps, in-process checks, yield limits, and packaging instructions.
How to Answer:
Explain that MFR is the source document from which Batch Manufacturing Records are created and is essential for process standardization.

Question 22

What is a deviation in the pharmaceutical industry?

Accepted Answer

Best Answer:
A deviation is any departure from an approved procedure, instruction, or established standard during manufacturing, packaging, testing, or documentation. Deviations can be planned (like equipment maintenance) or unplanned (like a power failure or wrong material used).
How to Answer:
Clearly define deviation and emphasize the need for timely documentation, investigation, and impact assessment to maintain product quality and compliance.

Question 23

What is the difference between planned and unplanned deviations?

Accepted Answer

Best Answer:
Planned deviation occurs when a known or intentional change is temporarily required from the approved procedure (e.g., using an alternate vendor with prior approval).
Unplanned deviation is an unexpected event like process errors, equipment malfunction, or human error that leads to non-conformance.
How to Answer:
Start by stating the key difference: intentional vs unintentional. Give simple examples to help clarify.

Question 24

What steps are involved in deviation handling?

Accepted Answer

Best Answer:
Immediate reporting and documentation of the deviation
Classification (minor, major, critical)
Investigation and root cause analysis
Risk assessment and impact analysis
CAPA recommendation
Review and approval by QA
Closure with proper documentation
How to Answer:
Use a structured step-by-step approach. Show you understand the importance of traceability, corrective action, and QA oversight.

Question 25

What is Change Control?

Accepted Answer

Best Answer:
Change Control is a formal process used to evaluate, document, approve, and implement changes to processes, systems, equipment, or documents to ensure they do not negatively impact product quality or compliance.
How to Answer:
Highlight that the purpose of Change Control is to ensure controlled, documented, and justified modifications that align with GMP standards.

Question 26

What are the key elements of a Change Control system?

Accepted Answer

Best Answer:
Change initiation and description
Justification for the change
Risk assessment and impact analysis
Approval from concerned departments (QA, production, QC, etc.)
Implementation and training (if required)
Verification and closure
How to Answer:
Emphasize cross-functional involvement, proper documentation, and QA approval before implementation.

Question 27

How do you perform a root cause analysis (RCA)?

Accepted Answer

Best Answer:
Root cause analysis is a systematic approach to identify the underlying cause of a problem or deviation. Common tools include:
5 Whys Technique
Fishbone (Ishikawa) Diagram
Fault Tree Analysis
How to Answer:
Mention one or two methods and briefly explain how they help you dig deeper into why the problem occurred, not just what happened.

Question 28

What is CAPA in pharmaceuticals?

Accepted Answer

Best Answer:
CAPA stands for Corrective and Preventive Action. It is a process that investigates deviations, determines the root cause, and implements corrective actions to fix the issue and preventive actions to ensure it doesn’t happen again.
How to Answer:
Mention that CAPA is a key tool in continuous improvement and GMP compliance. Always link it to preventing recurrence.

Question 29

What is the difference between corrective action and preventive action?

Accepted Answer

Best Answer:
Corrective Action is taken to eliminate the cause of an existing deviation or non-conformance.
Preventive Action is taken to eliminate the potential cause of a future deviation or non-conformance.
How to Answer:
Use a simple example. For instance, if equipment fails (corrective action = fix the issue, preventive action = schedule regular maintenance).

Question 30

Who is responsible for reviewing and closing deviations?

Accepted Answer

Best Answer:
The concerned department usually initiates the deviation and performs the initial investigation. The QA department is responsible for reviewing the investigation, approving the corrective/preventive actions, and officially closing the deviation after verifying effectiveness.
How to Answer:
Stress the collaborative role, but make it clear that QA has the final authority to review and close deviations as part of compliance oversight.

Question 31

What if you find repeated deviations of the same type?

Accepted Answer

Best Answer:
Repeated deviations indicate that either the root cause was not properly addressed or the corrective action was ineffective. In such cases, a thorough re-investigation should be initiated, and stronger CAPA or system-level changes should be considered. Sometimes, it may require retraining, process revision, or even equipment modification.
How to Answer:
Show that you understand the importance of trend analysis, continuous improvement, and proactive problem-solving.

Question 32

How is effectiveness of CAPA measured?

Accepted Answer

Best Answer:
Effectiveness is measured by evaluating whether the issue has been eliminated and has not recurred over a defined period. This can involve:
Monitoring for recurrence
Reviewing related deviations
Conducting follow-up audits
Checking documentation and training compliance
How to Answer:
Mention that an effective CAPA is sustainable and prevents future issues. Demonstrate that you follow through beyond implementation.

Question 33

What is validation in the pharmaceutical industry?

Accepted Answer

Best Answer:
Validation is a documented process that provides assurance a specific system, process, or equipment consistently produces a product meeting predetermined quality criteria. It ensures that the process is reliable and reproducible under defined conditions.
How to Answer:
Focus on the keywords: documented evidence, consistency, and reproducibility. Show you understand that validation is about building quality into the process, not just testing the final product.

Question 34

What is the difference between qualification and validation?

Accepted Answer

Best Answer:
Qualification is a part of validation. It refers to activities proving that equipment or systems are installed and operate correctly (IQ, OQ, PQ). Validation is broader and includes the entire process, not just equipment, ensuring that the process consistently delivers quality products.
How to Answer:
Make it simple: Qualification = equipment-specific, Validation = process-wide. Use terms like IQ, OQ, PQ to show clarity.

Question 35

What are the different types of process validation?

Accepted Answer

Best Answer:
Prospective Validation – Conducted before commercial production.
Concurrent Validation – Done during actual production for market.
Retrospective Validation – Based on historical batch data.
Revalidation – Performed after significant changes or at periodic intervals.
How to Answer:
Define each briefly. If unsure, remember: Prospective = before, Concurrent = during, Retrospective = after, Revalidation = repeat.

Question 36

What is IQ, OQ, and PQ?

Accepted Answer

Best Answer:
IQ (Installation Qualification): Verifies equipment is installed as per manufacturer specs and design.
OQ (Operational Qualification): Ensures equipment operates correctly under all anticipated operating ranges.
PQ (Performance Qualification): Confirms the equipment performs effectively and reproducibly in actual production.
How to Answer:
Stick to this three-step explanation. Make sure you link it to documented testing and real-time production conditions.

Question 37

What is cleaning validation and why is it important?

Accepted Answer

Best Answer:
Cleaning validation is a documented process to ensure that cleaning procedures remove residues of active pharmaceutical ingredients (APIs), excipients, and cleaning agents to an acceptable level. It ensures product quality and prevents cross-contamination between batches.
How to Answer:
Stress patient safety, regulatory compliance, and cross-contamination prevention. Mention that cleaning validation must be done for shared equipment.

Question 38

What are acceptance criteria in validation?

Accepted Answer

Best Answer:
Acceptance criteria are predefined limits or conditions that a process, equipment, or product must meet during validation. They are based on regulatory standards, product specifications, and risk assessments to ensure consistent quality.
How to Answer:
State that they’re set before validation begins and are critical for determining success or failure of the process.

Question 39

What is the Validation Master Plan (VMP)?

Accepted Answer

Best Answer:
The Validation Master Plan (VMP) is a high-level document that outlines the overall strategy, approach, responsibilities, and schedule for validation activities in a facility. It includes all systems, processes, equipment, and documents that require validation.
How to Answer:
Explain that the VMP is a roadmap and compliance blueprint. It ensures organization-wide consistency in validation practices.

Question 40

What is revalidation and when is it required?

Accepted Answer

Best Answer:
Revalidation is the repetition of validation to ensure continued performance after changes in process, equipment, facility, raw materials, or after a long production gap. It ensures the system still meets the predefined acceptance criteria.
How to Answer:
Emphasize change management and regulatory triggers for revalidation. Show you understand its role in lifecycle management.

Question 41

What is hold time study and how is it related to validation?

Accepted Answer

Best Answer:
Hold time study determines the maximum allowable time that intermediate or bulk products can be held before further processing without adversely affecting product quality. It is part of process validation and ensures product stability during manufacturing delays.
How to Answer:
Highlight that hold time studies are essential for process robustness and maintaining product integrity throughout manufacturing stages.

Question 42

What is worst-case approach in validation?

Accepted Answer

Best Answer:
A worst-case approach involves validating the most challenging or risky conditions within a process (e.g., highest load, slowest speed, most potent API) to ensure that if the process works under these conditions, it will work under normal conditions too.
How to Answer:
Say it’s a risk-based validation strategy used to ensure reliability and robustness under the most extreme yet possible scenarios.

Question 43

What is analytical method validation?

Accepted Answer

Best Answer:
Analytical method validation confirms that a specific method used for testing a product is suitable for its intended purpose. It involves checking parameters like accuracy, precision, specificity, linearity, detection limit, quantitation limit, and robustness.
How to Answer:
Link it to lab testing methods and ensuring reliable and reproducible results in quality control.

Question 44

What are the key documents generated during validation?

Accepted Answer

Best Answer:
Validation Protocol
Validation Report
Data Sheets and Logs
Test Plans and Results
Deviations and Investigations (if any)
Certificate of Analysis (CoA)
Training Records
Change Control records (if applicable)
How to Answer:
You don’t have to list all—just mention 4–5 and say these documents are auditable evidence of the validation process.

Question 45

What is a regulatory audit in the pharmaceutical industry?

Accepted Answer

Best Answer:
A regulatory audit is an official inspection conducted by external agencies like the US FDA, WHO, or local authorities to assess whether the pharmaceutical company complies with Good Manufacturing Practices (GMP) and other regulatory requirements. It covers documentation, processes, personnel practices, and product quality.
How to Answer:
Define it clearly and emphasize that it’s focused on ensuring product safety, quality, and regulatory compliance. Mention well-known bodies like US FDA or CDSCO for context.

Question 46

What is the difference between internal and external audits?

Accepted Answer

Best Answer:
Internal audits are conducted by the company’s own trained staff to assess and improve compliance before external audits.
External audits are conducted by regulatory authorities or third-party clients to verify GMP and other standards.
How to Answer:
Highlight that internal audits are proactive tools for identifying gaps, while external audits are formal evaluations by regulators or customers.

Question 47

What is the role of QA during audits?

Accepted Answer

Best Answer:
QA plays a central role during audits by coordinating the inspection, presenting and reviewing documents, responding to questions, ensuring audit readiness, and following up with CAPAs after the audit. QA also ensures any observations are documented and addressed properly.
How to Answer:
Show leadership and communication skills. Emphasize that QA is the key liaison between auditors and departments.

Question 48

What are the different types of audit findings?

Accepted Answer

Best Answer:
Critical: Major non-compliance that could impact product quality, safety, or efficacy.
Major: Significant deviation from GMP but not immediately affecting product quality.
Minor: Small issues that do not directly impact product quality but require correction.
Observation/Recommendation: Advisory notes for improvement.
How to Answer:
List and define each. Interviewers want to know if you understand the severity scale and response urgency for each type.

Question 49

What is a Form 483?

Accepted Answer

Best Answer:
Form 483 is issued by the US FDA to communicate observed GMP violations or non-compliances after an inspection. It lists specific findings that require correction and a written response from the company within 15 working days.
How to Answer:
Mention that while Form 483 is not a final enforcement action, it’s a serious warning and must be addressed immediately.

Question 50

What is the difference between a Form 483 and a Warning Letter?

Accepted Answer

Best Answer:
Form 483 is an initial inspection report with observations. A Warning Letter is a formal enforcement action issued if the FDA is not satisfied with the company’s response to the Form 483 or if the issues are serious enough.
How to Answer:
Explain that a Warning Letter implies continued non-compliance and can lead to product recalls or legal action.

Question 51

How should a company prepare for a regulatory audit?

Accepted Answer

Best Answer:
Conduct regular internal audits
Maintain GMP-compliant documentation
Train employees
Ensure housekeeping and hygiene
Keep validation, deviation, and CAPA records updated
Conduct mock audits
Maintain logbooks and calibration records accurately
How to Answer:
List practical steps. Show that preparation is continuous, not just before an audit.

Question 52

How do you handle audit stress or pressure from inspectors?

Accepted Answer

Best Answer:
Remain calm, professional, and honest. Only answer what is asked. Do not speculate or give assumptions. If unsure, admit and refer the query to the right person or offer to provide documentation later. Always maintain a respectful tone.
How to Answer:
Interviewers look for composure, clarity, and confidence. Focus on honesty and communication.

Question 53

What are mock audits and why are they important?

Accepted Answer

Best Answer:
Mock audits are internal rehearsals of regulatory inspections. They simulate real audits to identify gaps in compliance and train employees to respond confidently and correctly during actual inspections.
How to Answer:
Say they help ensure audit readiness and employee preparedness, and reduce the chance of major findings.

Question 54

What are some common observations during audits?

Accepted Answer

Best Answer:
Incomplete or backdated records
Untrained personnel performing critical tasks
Unclean or poorly maintained equipment
Uncontrolled changes without documentation
Poor documentation practices (e.g., overwriting, missing entries)
Deviations not closed or tracked properly
How to Answer:
Mention that most findings relate to documentation, training, and data integrity. Stress preventive actions.

Question 55

What is an audit trail and why is it important?

Accepted Answer

Best Answer:
An audit trail is a secure, time-stamped record of changes made to electronic data. It ensures data integrity by showing who made changes, when, and why. It is crucial for compliance with 21 CFR Part 11 and other global data integrity guidelines.
How to Answer:
Explain that audit trails support transparency, traceability, and prevent data manipulation.

Question 56

What should be done after the audit is completed?

Accepted Answer

Best Answer:
Review all observations
Initiate investigation for each finding
Develop a CAPA plan with timelines
Submit response to regulatory authority (if required)
Implement CAPAs and monitor effectiveness
Conduct a follow-up audit, if necessary
How to Answer:
Reinforce your understanding of post-audit responsibility, which is just as important as audit preparation.

Question 57

What is Quality Risk Management (QRM) in the pharmaceutical industry?

Accepted Answer

Best Answer:
Quality Risk Management (QRM) is a systematic process for identifying, evaluating, and controlling risks to the quality of pharmaceutical products. It helps prioritize actions based on risk level and ensures that resources are directed where they’re needed most to protect patient safety and product integrity.
How to Answer:
Define it simply and explain that QRM is about proactive decision-making to minimize quality issues before they occur.

Question 58

Why is QRM important in pharma?

Accepted Answer

Best Answer:
QRM ensures that potential quality issues are anticipated and addressed before they affect product safety or efficacy. It supports better decision-making, helps with resource allocation, ensures regulatory compliance, and contributes to continuous improvement.
How to Answer:
Mention that QRM aligns with patient-centric thinking — preventing harm before it happens. Highlight regulatory expectations and business efficiency.

Question 59

What are the key steps of the QRM process?

Accepted Answer

Best Answer:
Risk Identification – Recognizing potential risks to product quality
Risk Assessment – Analyzing the probability and severity
Risk Control – Taking measures to reduce risk to acceptable levels
Risk Communication – Sharing findings and decisions across teams
Risk Review – Monitoring the risks and their controls over time
How to Answer:
Use this five-step framework. Interviewers often look for structure, not just theory.

Question 60

What is the difference between risk assessment and risk management?

Accepted Answer

Best Answer:
Risk Assessment is the process of identifying and evaluating risks (likelihood, severity, and detectability).
Risk Management includes assessment but also involves making decisions about risk control, acceptance, and monitoring.
How to Answer:
Keep it clear: assessment = evaluation, management = action + monitoring.

Question 61

What are some commonly used QRM tools?

Accepted Answer

Best Answer:
FMEA (Failure Modes and Effects Analysis)
Risk Ranking and Filtering
Fault Tree Analysis (FTA)
HACCP (Hazard Analysis and Critical Control Points)
Ishikawa Diagram (Fishbone Analysis)
SWIFT (Structured What-If Technique)
How to Answer:
List 3–5 and mention that tool selection depends on complexity of the process and type of risk involved.

Question 62

What is FMEA? How is it applied in pharma?

Accepted Answer

Best Answer:
FMEA stands for Failure Modes and Effects Analysis. It is a structured approach to identifying all possible failures in a process and evaluating their impact, severity, likelihood, and detectability. Based on these, a risk priority number (RPN) is calculated to prioritize corrective actions.
How to Answer:
Explain that FMEA is used during process design, equipment qualification, and deviation investigations to proactively prevent failure.

Question 63

What is Risk Priority Number (RPN) and how is it calculated?

Accepted Answer

Best Answer:
RPN is a numerical score used in FMEA to prioritize risks. It is calculated as:
RPN = Severity × Occurrence × Detectability
Each parameter is rated on a scale (typically 1–10). A higher RPN indicates a higher risk and greater need for corrective action.
How to Answer:
Explain each term briefly. Example: a high severity but low occurrence may still need attention if detectability is poor.

Question 64

What factors influence the severity of a risk in pharma?

Accepted Answer

Best Answer:
Severity is influenced by the potential impact of a failure on product quality, patient safety, regulatory compliance, and business continuity. For instance, contamination in sterile injectable products poses a higher severity than cosmetic defects in packaging.
How to Answer:
Mention product type, route of administration, and intended use. Show you understand risk in the clinical context.

90+ Quality Assurance Interview Questions in Pharma Industry

Types of Quality Assurance Interview Questions in Pharma Industry

(With Examples)

1. GMP & Regulatory Compliance Questions

2. Documentation & SOP-Based Questions

3. Deviation, Change Control & CAPA Questions

4.Validation & Qualification Questions

5. Audit & Inspection Readiness Questions

6. Quality Risk Management (QRM) Questions

7. Production & IPQC Questions

8. Data Integrity & ALCOA Principles Questions

9. Behavioral & Situational Questions

Interview questions & answers

90+ Questions Asked in Quality Assurance Interview Questions in Pharma Industry

Quality Assurance Interview Questions in Pharma Industry: GMP & Regulatory Compliance Questions

Quality Assurance Interview Questions in Pharma Industry: Documentation & SOP-Based Questions

Quality Assurance Interview Questions in Pharma Industry: Deviation, Change Control & CAPA Questions

Quality Assurance Interview Questions in Pharma Industry: Validation & Qualification Questions

Quality Assurance Interview Questions in Pharma Industry: Audit & Inspection Readiness Questions

Quality Assurance Interview Questions in Pharma Industry: Quality Risk Management (QRM) Questions

Quality Assurance Interview Questions in Pharma Industry: Production & IPQC Questions

Quality Assurance Interview Questions in Pharma Industry: Data Integrity & ALCOA Principles Questions

Quality Assurance Interview Questions in Pharma Industry: Behavioral & Situational Questions

Frequently Asked Questions

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