Raw material auditing MCQs With Answer

Introduction: Raw material auditing is a critical component of pharmaceutical quality assurance, ensuring that materials used in drug manufacturing meet predefined standards for identity, purity, potency and safety. For M.Pharm students, understanding raw material audits involves learning supplier qualification, incoming inspection, documentation review, certificate of analysis evaluation, sampling plans, and regulatory expectations. This blog of MCQs with answers focuses on practical and regulatory aspects of raw material auditing, emphasizing risk-based approaches, pharmacopeial requirements, control of impurities, quarantine and release procedures, and corrective actions. These questions are designed to deepen comprehension and prepare students for audits, regulatory inspections and real-world quality decisions in pharmaceutical manufacturing.

Q1. What is the primary purpose of a raw material audit in a pharmaceutical company?

• To verify that the manufacturing equipment is calibrated
• To assess and ensure the quality, traceability and compliance of incoming raw materials
• To determine finished product packaging specifications
• To evaluate marketing strategies for raw materials

Correct Answer: To assess and ensure the quality, traceability and compliance of incoming raw materials

Q2. Which document from a supplier provides analytical test results for a specific batch and is reviewed during raw material auditing?

• Material Safety Data Sheet (MSDS)
• Certificate of Analysis (CoA)
• Purchase Order
• Supplier Quality Manual

Correct Answer: Certificate of Analysis (CoA)

Q3. During an incoming raw material inspection, which action is most appropriate when a material lacks a CoA?

• Release the material into production based on visual inspection
• Quarantine the material and request the CoA or perform in-house testing
• Return the material to stock for later use
• Mix the material with another batch to dilute risk

Correct Answer: Quarantine the material and request the CoA or perform in-house testing

Q4. Which sampling principle is commonly applied to ensure representative sampling of a large bulk raw material lot?

• Judgmental sampling
• Random and stratified sampling following pharmacopeial/taking patterns
• Only surface sampling
• Sampling from a single convenient location

Correct Answer: Random and stratified sampling following pharmacopeial/taking patterns

Q5. What is the role of supplier qualification in raw material auditing?

• To fix prices with preferred suppliers
• To evaluate and approve suppliers based on quality systems, capabilities, and compliance
• To determine shipment schedules
• To train suppliers on marketing

Correct Answer: To evaluate and approve suppliers based on quality systems, capabilities, and compliance

Q6. Which of the following is a regulatory expectation regarding raw materials for GMP compliance?

• Raw materials may be used without documentation if visually acceptable
• All raw materials must have documented specifications, identity testing, and traceability
• Only active pharmaceutical ingredients require documentation
• Documentation can be verbal with supplier confirmation

Correct Answer: All raw materials must have documented specifications, identity testing, and traceability

Q7. In an audit, what is the significance of a Material Review Board (MRB) decision for non-conforming raw material?

• MRB decides on promotional strategies for the material
• MRB determines disposition: accept, rework, return to supplier, or destroy
• MRB schedules future deliveries
• MRB updates supplier payment terms

Correct Answer: MRB determines disposition: accept, rework, return to supplier, or destroy

Q8. Which concept describes the practice of releasing raw materials based on supplier history and reduced testing?

• 100% testing strategy
• Quality by testing
• Supplier quality agreement and reduced testing through proven supplier control (reduced sampling)
• Visual release

Correct Answer: Supplier quality agreement and reduced testing through proven supplier control (reduced sampling)

Q9. What is a common risk-based factor to prioritize raw material audits?

• Color of the supplier logo
• Potential impact on product safety, impurity risk and criticality to final product
• Distance of supplier from manufacturing site
• Number of employees at the supplier

Correct Answer: Potential impact on product safety, impurity risk and criticality to final product

Q10. Which record should demonstrate traceability from finished product back to raw material batches during an audit?

• Marketing brochures
• Batch manufacturing records and material logs with batch numbers and COAs
• Supplier invoices only
• Employee training records

Correct Answer: Batch manufacturing records and material logs with batch numbers and COAs

Q11. How should a quality unit proceed if a COA shows a specification failure for an impurity that is below immediate safety concern but above spec?

• Ignore the failure and use the material
• Quarantine the material, perform confirmatory testing, evaluate impact, and decide disposition per change control/MRB
• Automatically destroy the material
• Ship material to production and notify the regulator

Correct Answer: Quarantine the material, perform confirmatory testing, evaluate impact, and decide disposition per change control/MRB

Q12. What is the difference between a Certificate of Analysis (CoA) and a Certificate of Suitability (CEP/BP/Ph. Eur)?

• CoA is issued for packaging only; CEP is for transport
• CoA provides batch-specific analytical results; CEP/Certificate of Suitability demonstrates monograph compliance for a substance to the pharmacopeia
• They are identical documents with different names
• CoA is regulatory approval; CEP is a shipping document

Correct Answer: CoA provides batch-specific analytical results; CEP/Certificate of Suitability demonstrates monograph compliance for a substance to the pharmacopeia

Q13. Which sampling plan parameter is most relevant when designing acceptance criteria for incoming raw materials?

• Ambient temperature in the warehouse
• Acceptance Quality Limit (AQL) and lot size
• Color of the raw material bags
• Supplier marketing claims

Correct Answer: Acceptance Quality Limit (AQL) and lot size

Q14. Why is quarantine labeling important for incoming raw materials?

• It makes the warehouse look organized
• It prevents unauthorized use before release by the quality unit and ensures traceability
• It speeds up shipments to customers
• It eliminates the need for record keeping

Correct Answer: It prevents unauthorized use before release by the quality unit and ensures traceability

Q15. During a supplier audit, which area should be inspected to evaluate contamination control for microbiologically sensitive excipients?

• Administrative office décor
• Manufacturing areas, HVAC, personnel hygiene, cleaning procedures, and environmental monitoring data
• Supplier cafeteria menu
• Supplier sales forecasts

Correct Answer: Manufacturing areas, HVAC, personnel hygiene, cleaning procedures, and environmental monitoring data

Q16. If a supplier implements a formulation change for an excipient, what is the correct control step from a raw material auditing perspective?

• Accept change without notice
• Supplier must notify, change control and requalification/impact assessment must be performed before acceptance
• Increase purchase orders to use existing stock quickly
• Ignore change if the price is reduced

Correct Answer: Supplier must notify, change control and requalification/impact assessment must be performed before acceptance

Q17. What is the significance of stability data for raw materials in auditing?

• It indicates how quickly a supplier can deliver
• It provides evidence of shelf life, storage conditions and suitability for use over time, affecting expiry dating and retest intervals
• It is only relevant for finished product packaging
• It replaces the need for incoming testing

Correct Answer: It provides evidence of shelf life, storage conditions and suitability for use over time, affecting expiry dating and retest intervals

Q18. Which corrective action is appropriate when a pattern of minor nonconformances is found across multiple raw material deliveries?

• Ignore since individual instances are minor
• Initiate supplier CAPA, reassess supplier qualification, and increase oversight/audits
• Terminate all supplier contracts immediately
• Reduce incoming inspection to save time

Correct Answer: Initiate supplier CAPA, reassess supplier qualification, and increase oversight/audits

Q19. Which analytical technique is commonly used to confirm identity of organic raw materials during audits?

• pH paper
• Infrared spectroscopy (IR), NMR or mass spectrometry depending on complexity
• Visual color comparison only
• Counting under a microscope

Correct Answer: Infrared spectroscopy (IR), NMR or mass spectrometry depending on complexity

Q20. What role does a Supplier Quality Agreement (SQA) play in raw material auditing?

• It schedules supplier social events
• It defines responsibilities, specifications, testing, change notification, audits and quality expectations between buyer and supplier
• It is only a financial contract for payment terms
• It replaces the need for incoming inspection entirely

Correct Answer: It defines responsibilities, specifications, testing, change notification, audits and quality expectations between buyer and supplier

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