Audit of product and process information MCQs With Answer

Introduction

This set of multiple-choice questions focuses on Audit of Product and Process Information, tailored for M.Pharm students preparing for advanced coursework and professional exams. The questions cover documentation practices, data integrity principles, batch record review, change control, release criteria, stability and labeling audits, traceability, and regulatory expectations. Each item probes practical understanding of how auditors evaluate product and process information to ensure compliance with GMP and regulatory requirements. Use these MCQs to assess your analytical skills, recognize typical audit findings, and reinforce best practices for managing product-related documentation throughout the product life cycle.

Q1. What is the primary purpose of auditing product and process information in a pharmaceutical facility?

• To validate the marketing strategy for a product
• To ensure product quality, safety, and regulatory compliance through verification of documented evidence
• To evaluate the financial performance of production lines
• To train new employees in manufacturing operations

Correct Answer: To ensure product quality, safety, and regulatory compliance through verification of documented evidence

Q2. Which document is most critical for verifying that a specific batch was manufactured according to approved procedures?

• Master Production and Control Record (MPR/Master Batch Record)
• Product Development Report
• Marketing Authorization Dossier
• Standard Operating Procedure for Purchasing

Correct Answer: Master Production and Control Record (MPR/Master Batch Record)

Q3. During an audit, which evidence demonstrates traceability of raw materials used in a batch?

• Training certificates of the material handlers
• Purchase order numbers only
• Material lot numbers, certificates of analysis, and material issuance records
• Vendor brochures describing the material

Correct Answer: Material lot numbers, certificates of analysis, and material issuance records

Q4. Which principle of data integrity emphasizes that recorded data should be attributable, legible, contemporaneous, original, and accurate?

• GAMP
• ALCOA
• ICH Q7
• CAPA

Correct Answer: ALCOA

Q5. What additional attribute is commonly added to ALCOA to address modern regulatory expectations?

• ALCOA+: adding Attributable, Legible, Contemporaneous, Original, Accurate only
• ALCOA+ with additions like Complete, Consistent, Enduring, and Available
• ALCOA++ emphasizing only security controls
• ALCOA- focusing on audit trails exclusively

Correct Answer: ALCOA+ with additions like Complete, Consistent, Enduring, and Available

Q6. Which audit finding would most likely indicate a deficiency in process information related to in-process control results?

• All in-process testing results are recorded with timestamps and initials
• In-process control samples were not taken at defined stages and results are missing
• The QC analyst has current training records
• Process parameters are within trending limits

Correct Answer: In-process control samples were not taken at defined stages and results are missing

Q7. When auditing change control documentation, what must be demonstrated to consider a change acceptable?

• Change was communicated internally but no risk assessment was performed
• Formal change request, justification, risk assessment, implementation plan, verification, and approval
• Change was implemented immediately without documentation to save time
• Only the vendor approved the change informally

Correct Answer: Formal change request, justification, risk assessment, implementation plan, verification, and approval

Q8. Which record is essential to confirm that finished product release testing has been completed and reviewed?

• Deviation log for unrelated equipment maintenance
• Finished product release certificates, QC test records, and release authorization
• Marketing brochures of the product
• Employee performance appraisals

Correct Answer: Finished product release certificates, QC test records, and release authorization

Q9. In the context of audits, what is the significance of a “batch record review” checklist?

• It is used to design a new product formula
• It guides systematic verification of critical documentation elements and compliance criteria for each batch
• It records lunch breaks of production staff
• It replaces the need for formal batch records

Correct Answer: It guides systematic verification of critical documentation elements and compliance criteria for each batch

Q10. Which type of audit evidence best supports the verification of stability data used in labeling claims?

• Emails discussing potential stability testing plans without data
• Complete stability study reports, raw data, statistical analysis, and conclusion supporting shelf life
• Sales forecasts projecting product demand
• Packaging mock-ups without stability rationale

Correct Answer: Complete stability study reports, raw data, statistical analysis, and conclusion supporting shelf life

Q11. What is an audit trail in computerized systems and why is it critical during audits of product/process information?

• A list of authorized users only; it is not relevant to data integrity
• A record that shows who made changes, what was changed, when, and why; essential to ensure data integrity and traceability
• A schedule of system backups that auditors do not review
• An external vendor log unrelated to system changes

Correct Answer: A record that shows who made changes, what was changed, when, and why; essential to ensure data integrity and traceability

Q12. During an audit, discovery of handwritten corrections in a batch record without signature or reason principally indicates a breach of which requirement?

• Vendor qualification
• Controlled temperature monitoring
• Documentation practices and data integrity principles requiring traceable corrections
• Label artwork approval

Correct Answer: Documentation practices and data integrity principles requiring traceable corrections

Q13. For audit purposes, what is the expected retention period for product-related records after the expiry date of the batch, per common regulatory guidance?

• Records may be discarded immediately after release
• Retention for a period that covers shelf life plus a defined number of years (commonly 1–5 years post expiry depending on regulation)
• Keep records only until the next audit
• Retain records for 30 days only

Correct Answer: Retention for a period that covers shelf life plus a defined number of years (commonly 1–5 years post expiry depending on regulation)

Q14. Which audit observation would indicate inadequate control of labeling information?

• Labels include approved lot number, expiry, and storage conditions matching documentation
• Label artwork revisions are not controlled and mismatches exist between label and approved specification
• Labels are stored in a locked cabinet
• Label proofs are signed and dated

Correct Answer: Label artwork revisions are not controlled and mismatches exist between label and approved specification

Q15. When auditing process validation information, which element provides highest assurance that the process consistently produces acceptable product?

• Single successful pilot batch without follow-up monitoring
• Comprehensive process validation reports with established critical process parameters, acceptance criteria, and ongoing monitoring (continuous verification)
• Marketing claims of consistent performance
• Operator testimonials about process stability

Correct Answer: Comprehensive process validation reports with established critical process parameters, acceptance criteria, and ongoing monitoring (continuous verification)

Q16. An auditor finds multiple repeat deviations with ineffective CAPA. What is the primary concern regarding product and process information?

• Supply chain timelines
• Systemic failures in documentation, root cause analysis, and preventive actions that may compromise product quality
• Employee satisfaction scores
• External communication policies

Correct Answer: Systemic failures in documentation, root cause analysis, and preventive actions that may compromise product quality

Q17. Which regulatory document would auditors consult to check expectations for documentation and records in pharmaceutical manufacturing?

• Taxation Code
• Good Manufacturing Practice (GMP) guidelines such as EU GMP or FDA 21 CFR parts relevant to pharmaceuticals
• Local employment laws only
• International marketing standards unrelated to GMP

Correct Answer: Good Manufacturing Practice (GMP) guidelines such as EU GMP or FDA 21 CFR parts relevant to pharmaceuticals

Q18. How should auditors treat electronic signatures and records during product/process information audits?

• Ignore them and only review paper records
• Verify that electronic records are secure, have validated systems, enforce identity-based access, and maintain reliable audit trails
• Assume they are always compliant without verification
• Require conversion of all electronic records to handwritten forms

Correct Answer: Verify that electronic records are secure, have validated systems, enforce identity-based access, and maintain reliable audit trails

Q19. What is the role of retention samples in auditing product information?

• To serve as display samples for marketing
• To provide physical product evidence for stability checks, investigations, and to confirm batch conformance over time
• To be used for routine employee training exercises
• To replace QC test results

Correct Answer: To provide physical product evidence for stability checks, investigations, and to confirm batch conformance over time

Q20. Which approach should an auditor take when evaluating the effectiveness of documentation controls across multiple departments?

• Review a representative sample of records, interview personnel, assess cross-functional interfaces, and verify adherence to SOPs and data integrity principles
• Only inspect records in the quality department without cross-checking production
• Rely solely on management statements of compliance
• Check only the most recent batch and ignore historical records

Correct Answer: Review a representative sample of records, interview personnel, assess cross-functional interfaces, and verify adherence to SOPs and data integrity principles

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