Internal vs external customers MCQs With Answer

Introduction: Internal vs External Customers MCQs With Answer

This quiz set is designed specifically for M.Pharm students studying Quality Management Systems (MQA 102T). It focuses on the practical distinctions between internal and external customers within pharmaceutical organizations, exploring how customer-orientation drives quality, compliance and continual improvement. Questions cover examples from production, QA/QC, suppliers, contract manufacturing and regulatory interactions, and examine metrics, complaint handling, service-level expectations and cross-functional coordination. These MCQs emphasize real-world scenarios that students will encounter in industry, helping them apply QMS principles to maintain product quality, protect patient safety and meet regulatory requirements.

Q1. What best defines an internal customer in a pharmaceutical quality management system?

• An individual or department within the same organization that receives products, services or information from another internal unit
• A patient who purchases the final drug product from a pharmacy
• An external distributor who markets the product
• A regulatory inspector auditing the facility

Correct Answer: An individual or department within the same organization that receives products, services or information from another internal unit

Q2. Which of the following is a typical example of an internal customer for the Quality Control (QC) laboratory?

• The hospital purchasing the finished drug
• The production department requesting product release testing
• The raw material supplier delivering components
• The national regulatory authority issuing a licence

Correct Answer: The production department requesting product release testing

Q3. Who would be considered an external customer in the pharmaceutical industry?

• The validation team receiving protocols from engineering
• The packaging department requesting label artwork
• The patient consuming the medicine
• The internal IT helpdesk supporting LIMS

Correct Answer: The patient consuming the medicine

Q4. Which practice is most effective for managing expectations between internal customers and service-providing departments?

• Informal verbal requests only
• Service-level agreements (SLAs) and documented turnaround times
• Ignoring requests until an external audit arrives
• Relying solely on annual performance reviews

Correct Answer: Service-level agreements (SLAs) and documented turnaround times

Q5. In a pharma plant, a QA review note requesting revision of a batch record is an example of:

• An external customer complaint
• Internal customer feedback from QA to production
• A regulatory deficiency reported by a health authority
• A supplier quality notification

Correct Answer: Internal customer feedback from QA to production

Q6. Which of the following is primarily an external customer for a pharmaceutical manufacturer?

• The downstream packaging line receiving filled vials
• The in-house validation group
• The wholesale distributor purchasing finished product
• The internal maintenance crew

Correct Answer: The wholesale distributor purchasing finished product

Q7. Which outcome is most likely when internal customer complaints about documentation delays are ignored?

• Improved regulatory relationships
• Triggering CAPA and increased risk of batch delays
• Reduction in external customer complaints automatically
• Faster product development timelines

Correct Answer: Triggering CAPA and increased risk of batch delays

Q8. Which metric best reflects internal customer service performance for a QC testing lab?

• Number of external distributors served
• On-time test report issuance against agreed turnaround times (SLA compliance)
• Total annual sales revenue
• Number of regulatory inspections per year

Correct Answer: On-time test report issuance against agreed turnaround times (SLA compliance)

Q9. Poor internal customer service between departments most directly leads to which pharmaceutical quality risk?

• Accelerated regulatory approvals
• Delayed batch release and potential nonconformities
• Improved clinical outcomes
• Lower supplier lead times

Correct Answer: Delayed batch release and potential nonconformities

Q10. Where should external customer complaints be formally recorded according to GMP practices?

• On a verbal phone log only
• In the customer complaint handling system or complaint log
• Nowhere—only internal issues are recorded
• Only in marketing presentation slides

Correct Answer: In the customer complaint handling system or complaint log

Q11. Which function typically leads the investigation of an external product complaint in a pharmaceutical company?

• Quality unit coordinating cross-functional investigation
• External distributor without involvement of the manufacturer
• The cafeteria services
• Only the legal department without technical input

Correct Answer: Quality unit coordinating cross-functional investigation

Q12. The “Voice of the Customer” (VOC) in pharma includes which of the following inputs?

• Only manufacturing batch records
• Patient adverse event reports, prescriber feedback and market complaints
• Only supplier invoices
• The company holiday calendar

Correct Answer: Patient adverse event reports, prescriber feedback and market complaints

Q13. Which quality management standard explicitly promotes the concept of internal customers to improve processes?

• ISO 9001 (Quality management systems)
• US Pharmacopeia monographs
• Pharmacopoeial testing methods only
• Financial accounting standards

Correct Answer: ISO 9001 (Quality management systems)

Q14. Why is supplier performance monitoring essential for meeting external customer expectations?

• Supplier performance has no impact on final product quality
• Because supplier quality and delivery directly affect final product quality and customer satisfaction
• Only to increase the number of suppliers
• To reduce internal communications between departments

Correct Answer: Because supplier quality and delivery directly affect final product quality and customer satisfaction

Q15. In analytical sample flow, which department is the internal customer of the QC laboratory?

• The external wholesale buyer
• The production department submitting samples for analysis
• The national regulatory authority issuing licences
• The external courier company

Correct Answer: The production department submitting samples for analysis

Q16. Which of the following is an example of an internal customer requirement within a QMS?

• Regulatory guidance document from a health authority
• Timely provision of validated analytical results to enable batch release
• Prescription practices of physicians
• Retail pricing strategy of a pharmacy chain

Correct Answer: Timely provision of validated analytical results to enable batch release

Q17. In contract manufacturing, who is typically the external customer?

• The in-house maintenance team
• The contract sponsor or marketing authorization holder who outsources manufacture
• The internal quality control analyst
• The facility janitorial staff

Correct Answer: The contract sponsor or marketing authorization holder who outsources manufacture

Q18. Which of the following is NOT normally considered an internal customer?

• The downstream packaging line receiving materials from upstream production
• The procurement team ordering consumables for manufacturing
• The national regulatory authority inspecting compliance
• The warehouse team requesting labeling instructions

Correct Answer: The national regulatory authority inspecting compliance

Q19. Which metric combination is appropriate for measuring external customer satisfaction with a pharmaceutical product?

• Complaint rate, product returns and customer satisfaction survey results
• Number of internal memos and cafeteria complaints
• Only the number of internal audits conducted
• Server uptime for internal email only

Correct Answer: Complaint rate, product returns and customer satisfaction survey results

Q20. What is a primary benefit of using cross-functional teams to serve internal customers in pharma QMS?

• Slower decision-making and siloed work
• Faster problem resolution, improved product quality and reduced errors
• Increased number of external complaints by default
• Fewer process controls and documentation

Correct Answer: Faster problem resolution, improved product quality and reduced errors

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