Purchase specifications for equipment and raw materials MCQs With Answer

Purchase specifications for equipment and raw materials MCQs With Answer are essential study tools for B. Pharm students preparing for roles in quality assurance, production, and regulatory compliance. This introduction covers specification components such as identification, assay, purity, acceptance criteria, sampling plans, storage, labeling, and documentation, along with equipment requirements like qualification (IQ/OQ/PQ), calibration, maintenance, and safety. Emphasis is placed on supplier qualification, certificates of analysis, pharmacopoeial standards (USP/EP/ICH), analytical methods, and risk-based change control. Practicing these MCQs will deepen your understanding of GMP, CQAs/CPPs, and decision-making for accepting or rejecting materials and equipment. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary purpose of a purchase specification for a raw material?

• To list only the supplier contact details
• To define quality attributes, acceptance criteria and test methods
• To describe production processes where the material is used
• To set the price and delivery schedule

Correct Answer: To define quality attributes, acceptance criteria and test methods

Q2. Which of the following is NOT normally part of a raw material specification?

• Identification tests (e.g., IR, HPLC)
• Assay or potency limits
• Cleaning validation protocol for manufacturing equipment
• Storage and packaging conditions

Correct Answer: Cleaning validation protocol for manufacturing equipment

Q3. Acceptance criteria in purchase specifications are most appropriately established based on which source?

• Supplier marketing brochure
• Random decisions by procurement
• Pharmacopoeial standards, regulatory guidance and risk assessment
• Lowest cost bid among suppliers

Correct Answer: Pharmacopoeial standards, regulatory guidance and risk assessment

Q4. What is the correct sequence of equipment qualification activities?

• PQ → OQ → IQ
• OQ → IQ → PQ
• IQ → OQ → PQ
• IQ → PQ → OQ

Correct Answer: IQ → OQ → PQ

Q5. A Certificate of Analysis (COA) accompanying a raw material should typically include:

• Batch number and analytical results against specification
• Supplier name and manufacturing date
• Analytical method references and limits
• All of the above

Correct Answer: All of the above

Q6. What is the difference between a retest period and shelf life stated in a purchase specification?

• Retest period applies to finished products, shelf life to raw materials
• Retest period applies to raw material reassessment; shelf life applies to finished product stability
• They are interchangeable terms
• Retest period is always longer than shelf life

Correct Answer: Retest period applies to raw material reassessment; shelf life applies to finished product stability

Q7. Critical Quality Attributes (CQAs) in material specifications refer to:

• Operational schedules for equipment
• Physical, chemical, biological properties that must be within limits to ensure product quality
• Supplier payment terms
• Warehouse rack locations

Correct Answer: Physical, chemical, biological properties that must be within limits to ensure product quality

Q8. A statistically sound sampling plan for incoming raw materials should be based on:

• Fixed single sample for all lots regardless of size
• Lot size, acceptable quality level (AQL) and risk assessment
• Supplier preference
• Only visual inspection data

Correct Answer: Lot size, acceptable quality level (AQL) and risk assessment

Q9. Supplier qualification for critical raw materials commonly includes which activity?

• Only evaluating price competitiveness
• Supplier audits, review of quality systems, and performance history
• Avoiding documentation to speed procurement
• Accepting first shipment without testing

Correct Answer: Supplier audits, review of quality systems, and performance history

Q10. Frequency of equipment calibration in the specification is best determined by:

• Manufacturer recommendation, usage and risk assessment
• Random selection each month
• Only when equipment breaks down
• Whenever procurement requests it

Correct Answer: Manufacturer recommendation, usage and risk assessment

Q11. Which guideline defines thresholds for residual solvents to include in solvent specifications?

• ICH Q3C
• ICH Q1A
• USP chapter on dissolution
• GMP Annex 11

Correct Answer: ICH Q3C

Q12. Typical identification tests in a raw material specification may include:

• Melting point, IR spectrum, and HPLC retention time
• Only supplier trade name
• Warehouse temperature logs
• Procurement invoice number

Correct Answer: Melting point, IR spectrum, and HPLC retention time

Q13. Visual inspection criteria in a purchase specification should address:

• Color, particulate matter, foreign matter and packaging integrity
• Supplier profit margin
• Batch release signatures
• Sales forecast

Correct Answer: Color, particulate matter, foreign matter and packaging integrity

Q14. When a raw material specification is changed for increased assay limits, the appropriate action is to:

• Implement change immediately without testing
• Perform change control, risk assessment and requalification where necessary
• Ignore the change unless supplier complains
• Sell off existing stock

Correct Answer: Perform change control, risk assessment and requalification where necessary

Q15. Traceability of raw materials is best ensured by which practice?

• Using generic labels without lot numbers
• Assigning unique lot numbers and maintaining COA and batch records
• Discarding supplier documentation after receipt
• Storing materials in unmarked containers

Correct Answer: Assigning unique lot numbers and maintaining COA and batch records

Q16. For primary container-closure systems intended for parenteral products, which specification test is critical?

• Extractables and leachables studies and container compatibility testing
• Only the color of the carton
• Supplier reimbursement policy
• Marketing label design

Correct Answer: Extractables and leachables studies and container compatibility testing

Q17. Which document formally records acceptance of incoming material after testing against the purchase specification?

• Certificate of analysis (COA) and release note or material release record
• Supplier marketing brochure
• Invoice only
• Purchase order only

Correct Answer: Certificate of analysis (COA) and release note or material release record

Q18. Which analytical attribute is frequently listed as critical for active pharmaceutical ingredients (APIs)?

• Assay/potency and impurity profile
• Supplier’s logo quality
• Warehouse shelf color
• Procurement invoice date

Correct Answer: Assay/potency and impurity profile

Q19. In equipment specifications, what does a Performance Qualification (PQ) demonstrate?

• That equipment is installed correctly
• That equipment performs consistently under normal production conditions
• That staff are trained on procurement processes
• That the supplier delivered on time

Correct Answer: That equipment performs consistently under normal production conditions

Q20. Measurement uncertainty and method precision should be considered in specifications when:

• Defining acceptance limits and interpreting analytical results
• Only for visual inspection
• Never; qualitative checks are enough
• Only for marketing purposes

Correct Answer: Defining acceptance limits and interpreting analytical results

Q21. Which of the following best describes a pharmacopoeial reference in a purchase specification?

• A legally recognized test or limit (e.g., USP, EP) used for identification and assay
• A supplier’s internal test method only
• A marketing claim
• An invoice term

Correct Answer: A legally recognized test or limit (e.g., USP, EP) used for identification and assay

Q22. Which control is most appropriate for non-pharmacopoeial excipients critical to product performance?

• Specify functional tests (e.g., viscosity, particle size) and supplier performance history
• Accept any material labeled as “pharmaceutical grade”
• Rely solely on price
• Use only visual checks

Correct Answer: Specify functional tests (e.g., viscosity, particle size) and supplier performance history

Q23. If a COA shows a marginal out-of-specification impurity just above limit, the best immediate action is to:

• Reject without investigation
• Perform investigation, verify test method and consider additional testing or supplier discussion
• Ignore and release material
• Sell material to another company

Correct Answer: Perform investigation, verify test method and consider additional testing or supplier discussion

Q24. Which is a key element of equipment specification related to safety?

• Inclusion of safety interlocks, guarding, and operator protection requirements
• Only the color of the equipment
• Supplier payment terms
• Number of marketing brochures included

Correct Answer: Inclusion of safety interlocks, guarding, and operator protection requirements

Q25. A material’s shelf-life on a purchase specification should be established using:

• Accelerated and real-time stability data or supplier stability data with justification
• Only the manufacturing date without testing
• Supplier claims without supporting data
• Random calendar dates

Correct Answer: Accelerated and real-time stability data or supplier stability data with justification

Q26. Which regulatory principle requires that purchase specifications are documented, controlled and followed?

• Good Documentation Practice (GDP) and Good Manufacturing Practice (GMP)
• Only marketing guidelines
• Local consumer preferences
• Procurement convenience

Correct Answer: Good Documentation Practice (GDP) and Good Manufacturing Practice (GMP)

Q27. For an incoming API, which impurity test is typically important to include in the specification?

• Related substances/impurities by validated HPLC
• Number of pallets used in shipment
• Factory cafeteria menu
• Invoice payment date

Correct Answer: Related substances/impurities by validated HPLC

Q28. Which approach is appropriate when creating a specification for a new excipient with limited history?

• Include broad, conservative acceptance criteria, stability studies and supplier qualifications
• Use the specification of any other excipient
• Avoid testing to save time
• Permit unlimited supplier variations

Correct Answer: Include broad, conservative acceptance criteria, stability studies and supplier qualifications

Q29. Which document should be checked to confirm that an instrument used for testing conforms to specification?

• Calibration certificate and validation/qualification records
• Only the original equipment brochure
• Supplier invoice only
• Employee ID badge

Correct Answer: Calibration certificate and validation/qualification records

Q30. Risk-based change control for purchase specifications should prioritize changes that:

• Affect critical quality attributes, patient safety, or regulatory compliance
• Only affect stationery used in the office
• Are purely cosmetic on non-essential documents
• Relate solely to supplier logo color

Correct Answer: Affect critical quality attributes, patient safety, or regulatory compliance

G S Sachin

I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.

Mail- Sachin@pharmacyfreak.com