Classification of customers MCQs With Answer

Introduction: Quality Management Systems require a clear understanding of who the customers are and what they expect. This quiz set on Classification of Customers is designed for M.Pharm students to deepen comprehension of different customer types encountered in pharmaceutical quality systems—internal and external, direct and indirect, primary users, regulatory bodies, payers, prescribers, and intermediaries. Questions emphasize customer-driven quality attributes, regulatory perspectives, and customer-related requirements in ISO and GMP contexts. By practicing these MCQs, students will sharpen skills in identifying customer roles, interpreting their needs for product quality and documentation, and applying customer classification concepts to complaint handling, validation, and supplier selection in pharmaceutical operations.

Q1. Which of the following best defines an ‘external customer’ in a pharmaceutical quality system?

• Any department within the same company that uses product information
• A regulatory authority that inspects manufacturing sites
• A patient, prescriber, distributor, or regulatory body outside the manufacturing organization
• An internal auditor or quality assurance team

Correct Answer: A patient, prescriber, distributor, or regulatory body outside the manufacturing organization

Q2. In the context of ISO 9001, which classification emphasizes customers who directly receive the finished pharmaceutical product?

• Internal customers
• Intermediate suppliers
• End users
• Regulatory customers

Correct Answer: End users

Q3. Which customer type is primarily concerned with compliance to GMP and submission dossiers rather than product use?

• Patients
• Regulatory authorities
• Community pharmacists
• Clinical trial volunteers

Correct Answer: Regulatory authorities

Q4. What classification would a hospital pharmacy represent when purchasing sterile injectables from a manufacturer?

• Internal customer
• Distributor
• Direct external customer (institutional buyer)
• Regulatory observer

Correct Answer: Direct external customer (institutional buyer)

Q5. Which term best describes customers such as procurement departments within the same company that request materials or services?

• External stakeholders
• Internal customers
• End users
• Regulatory bodies

Correct Answer: Internal customers

Q6. In pharmaceutical QMS, which customer classification is most relevant when defining Critical-to-Quality (CTQ) attributes?

• Regulatory inspectors exclusively
• All customers who interact with the product or documentation, including patients and prescribers
• Only the final distributor
• Only sales and marketing teams

Correct Answer: All customers who interact with the product or documentation, including patients and prescribers

Q7. Which classification applies to a contract research organization (CRO) conducting studies on behalf of a sponsor?

• End user
• Downstream patient
• Contract customer / client (external)
• Regulatory authority

Correct Answer: Contract customer / client (external)

Q8. Which customer type is typically considered when writing a User Requirements Specification (URS) for a manufacturing system?

• Internal operators, QA, maintenance, and external regulatory expectations
• Only external distributors
• Only the marketing department
• Only patients

Correct Answer: Internal operators, QA, maintenance, and external regulatory expectations

Q9. Which of the following best describes a ‘secondary customer’ in pharmaceutical supply chains?

• A patient who takes the medication
• An intermediary such as a wholesaler or logistics provider who does not directly consume the product
• A regulatory inspector
• An internal QC analyst

Correct Answer: An intermediary such as a wholesaler or logistics provider who does not directly consume the product

Q10. When categorizing customers for complaint investigation, which attribute is most important?

• Customer’s geographic location only
• Severity of impact on patient safety and product use
• Customer’s payment history
• Marketing potential of the customer

Correct Answer: Severity of impact on patient safety and product use

Q11. Which classification is used for a physician influencing prescribing behavior but not directly purchasing the product?

• Purchasing customer
• Influencer or prescriber (indirect customer)
• Internal customer
• Regulatory customer

Correct Answer: Influencer or prescriber (indirect customer)

Q12. In supplier qualification, treating the supplier as a ‘customer’ of requirements helps ensure which outcome?

• Faster marketing approvals
• Suppliers understand and meet defined specifications and quality expectations
• Increased sales promotions
• Lower regulatory oversight

Correct Answer: Suppliers understand and meet defined specifications and quality expectations

Q13. Which customer classification is appropriate for internal documentation users such as validation and QA teams?

• External end users
• Internal customers
• Patients
• Regulators

Correct Answer: Internal customers

Q14. For pharmacovigilance reporting, which customer classification is prioritized?

• Market research groups
• Regulatory authorities and patients/healthcare professionals reporting adverse events
• Sales representatives only
• Manufacturing engineers

Correct Answer: Regulatory authorities and patients/healthcare professionals reporting adverse events

Q15. Which of the following describes a ‘key account’ in pharmaceutical distribution?

• A single patient using the medication occasionally
• A large hospital chain or national wholesaler representing strategic volume and requiring tailored services
• An internal maintenance crew
• A local pharmacist with minimal orders

Correct Answer: A large hospital chain or national wholesaler representing strategic volume and requiring tailored services

Q16. Which classification captures customers who will never directly buy the product but whose acceptance is essential (e.g., ethics committees, IRBs)?

• Direct purchasers
• Indirect or non-commercial stakeholders
• Internal production staff
• Logistics customers

Correct Answer: Indirect or non-commercial stakeholders

Q17. In customer segmentation for quality improvement, why is it important to distinguish between ‘loyal’ and ‘occasional’ customers?

• Only loyal customers are regulated
• Different segments have different expectations and risk profiles affecting corrective/preventive actions
• Occasional customers do not report complaints
• It determines the fill volume for batch manufacture

Correct Answer: Different segments have different expectations and risk profiles affecting corrective/preventive actions

Q18. Which customer classification best fits a regulatory submission reviewer evaluating a dossier but not handling the physical product?

• End user
• Indirect regulatory customer
• Distributor
• Final payer

Correct Answer: Indirect regulatory customer

Q19. How are ‘internal customers’ typically involved in continuous improvement activities within a pharmaceutical QMS?

• They are excluded from improvement initiatives
• They provide process feedback, report nonconformities, and help define user requirements for changes
• They only follow instructions from external vendors
• They act as external auditors

Correct Answer: They provide process feedback, report nonconformities, and help define user requirements for changes

Q20. Which classification would best describe health insurance payers who influence product access and reimbursement?

• End users
• Payers/stakeholders influencing market access
• Internal QA staff
• Clinical trial subjects

Correct Answer: Payers/stakeholders influencing market access

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