cGMP principles MCQs With Answer

cGMP Principles MCQs With Answer for M.Pharm (Modern Pharmaceutics – MPH 103T)

Current Good Manufacturing Practice (cGMP) forms the backbone of pharmaceutical quality systems, ensuring that medicines are safe, effective, and consistently manufactured. For M.Pharm students, mastering cGMP means understanding regulatory expectations, risk-based approaches, validation science, and robust documentation practices. This quiz set focuses on practical, exam- and industry-relevant facets of cGMP: data integrity (ALCOA+), qualification and validation, ICH guidelines (Q8, Q9, Q10), environmental control, water systems, sterile processing, OOS/OOT, change control, and CAPA. Each question targets principles that drive compliant operations and inspections, helping you connect global regulations (21 CFR, EU GMP, WHO, Schedule M) with day-to-day shop-floor controls and decision-making. Use this to assess depth, not just recall.

Q1. Which regulation primarily defines the minimum cGMP requirements for finished pharmaceuticals in the United States?

• 21 CFR Parts 210 and 211
• 21 CFR Part 11
• ICH Q9
• EU GMP Annex 1

Correct Answer: 21 CFR Parts 210 and 211

Q2. What is the main intent of ICH Q9 in pharmaceutical quality systems?

• To eliminate all manufacturing risks via zero-defect strategies
• To define bioequivalence testing requirements
• To provide a systematic process for assessing, controlling, communicating, and reviewing risks to product quality
• To establish pharmacopoeial monographs

Correct Answer: To provide a systematic process for assessing, controlling, communicating, and reviewing risks to product quality

Q3. In data integrity, ALCOA+ expands ALCOA by adding which elements?

• Compliant, Confidential, Controlled, Calibrated
• Complete, Consistent, Enduring, Available
• Calculated, Corroborated, Confirmed, Archived
• Correct, Canonical, Cumulative, Accessible

Correct Answer: Complete, Consistent, Enduring, Available

Q4. Which sequence correctly reflects the modern process validation lifecycle per FDA guidance?

• Process Qualification → Process Design → Continued Process Verification
• Process Design → Process Qualification → Continued Process Verification
• Continued Process Verification → Process Design → Process Qualification
• Process Qualification → Continued Process Verification → Process Design

Correct Answer: Process Design → Process Qualification → Continued Process Verification

Q5. What is the proper order of equipment qualification stages?

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

Correct Answer: DQ → IQ → OQ → PQ

Q6. In cleanroom classification, EU GMP Grade A corresponds most closely to which ISO class?

• ISO Class 8
• ISO Class 7
• ISO Class 5
• ISO Class 4

Correct Answer: ISO Class 5

Q7. Which statement about Water for Injection (WFI) is most accurate under cGMP expectations?

• WFI has no endotoxin limit and is used only for cleaning non-product-contact equipment
• WFI must meet an endotoxin specification and is used for parenteral manufacturing and final equipment rinse
• WFI is interchangeable with Purified Water for all dosage forms
• WFI is produced only by reverse osmosis in all pharmacopeias

Correct Answer: WFI must meet an endotoxin specification and is used for parenteral manufacturing and final equipment rinse

Q8. The target Sterility Assurance Level (SAL) for terminally sterilized parenteral products is generally:

• 10^-2
• 10^-3
• 10^-6
• 10^-9

Correct Answer: 10^-6

Q9. Which is NOT a commonly used scientific basis for establishing cleaning validation acceptance limits?

• Health-based exposure limits (e.g., ADE/PDE)
• Dose-based criteria (e.g., 0.001 of the minimum therapeutic dose)
• Analytical method capability and recovery data
• Organoleptic thresholds (taste/smell) of the residue

Correct Answer: Organoleptic thresholds (taste/smell) of the residue

Q10. 21 CFR Part 11 specifically addresses:

• Electronic records and electronic signatures requirements
• Microbiological media fill design
• Bioavailability study design
• Container-closure integrity testing

Correct Answer: Electronic records and electronic signatures requirements

Q11. Under cGMP, an Out-of-Specification (OOS) result best refers to:

• A trend toward the edge of the historical mean without exceeding limits
• A single result that does not meet a defined specification criterion
• A result outside alert level but within action level
• A value that differs from another analyst’s value by 5%

Correct Answer: A single result that does not meet a defined specification criterion

Q12. Which change should be controlled via a formal change control system in a PQS?

• Any planned change that could impact product quality, validated state, or regulatory commitments
• Personal calendar updates of the QA head
• Marketing team’s branding color palette
• Holiday schedule for the cafeteria

Correct Answer: Any planned change that could impact product quality, validated state, or regulatory commitments

Q13. The primary purpose of line clearance before batch initiation is to:

• Verify operator training records
• Prevent mix-ups and cross-contamination by removing previous materials and documents
• Calibrate production equipment
• Authorize batch release to market

Correct Answer: Prevent mix-ups and cross-contamination by removing previous materials and documents

Q14. Which item is mandatory in a Master Production (Batch) Record per cGMP?

• Statement of theoretical yield and acceptable yield ranges at appropriate phases
• Supplier’s annual sales revenue
• Marketing launch timeline
• Equipment purchase prices

Correct Answer: Statement of theoretical yield and acceptable yield ranges at appropriate phases

Q15. According to ICH Q1A(R2), the standard accelerated stability condition for most drug products is:

• 25°C/60% RH for 12 months
• 30°C/65% RH for 6 months
• 40°C/75% RH for 6 months
• 50°C/20% RH for 3 months

Correct Answer: 40°C/75% RH for 6 months

Q16. Which method is typically used to verify HEPA/ULPA filter integrity in cleanrooms?

• pH indicator strips
• Aerosol (PAO/DOP) challenge with photometer scanning
• Conductivity measurement
• Gas chromatography of room air

Correct Answer: Aerosol (PAO/DOP) challenge with photometer scanning

Q17. For sterile filtration of solutions, which statement is most appropriate under cGMP?

• Only a pre-use integrity test is required
• Post-use integrity testing (e.g., bubble point or diffusive flow) must confirm filter performance
• Integrity testing is unnecessary if using a 0.22 μm rated filter
• Integrity tests are replaced by bioburden testing

Correct Answer: Post-use integrity testing (e.g., bubble point or diffusive flow) must confirm filter performance

Q18. Which is NOT typically a component of a supplier qualification program in cGMP?

• Onsite audits or assessments
• Quality agreements defining responsibilities and change notification
• Incoming material testing and ongoing performance monitoring
• Negotiated payment terms and discount structures

Correct Answer: Negotiated payment terms and discount structures

Q19. Which tool is commonly used for root cause analysis during CAPA investigations?

• Ishikawa (fishbone) diagram
• Monte Carlo pricing model
• Fourier transform spectroscopy
• Hedonic regression

Correct Answer: Ishikawa (fishbone) diagram

Q20. According to Good Documentation Practices (GDP), the correct way to correct a handwritten entry is to:

• Erase the entry completely and rewrite
• Use correction fluid to cover the mistake
• Strike through with a single line, retain legibility, add reason if required, sign and date
• Black out the error to ensure it cannot be read

Correct Answer: Strike through with a single line, retain legibility, add reason if required, sign and date

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