US cGMP Part 210 & 211 MCQs With Answer

Introduction: This quiz collection on US cGMP Parts 210 and 211 is designed specifically for M.Pharm students preparing for exams and regulatory practice. It focuses on the fundamentals and practical expectations of the Current Good Manufacturing Practice regulations that govern the manufacture, processing, packing, and holding of drug products in the United States. Questions cover scope and applicability, responsibilities of the quality unit, documentation (master and batch records), validation, stability, labeling, investigations, environmental controls, and FDA inspection rights. The goal is to deepen conceptual understanding and application of regulatory requirements so students can confidently interpret and implement cGMP in real-world pharmaceutical operations.

Q1. What is the primary objective of 21 CFR Parts 210 and 211 (US cGMP) for pharmaceutical manufacturers?

• To control the marketing and pricing of drugs
• To ensure drugs are consistently produced and controlled to meet safety, identity, strength, quality, and purity requirements
• To mandate clinical trial protocols for new drug applications
• To regulate pharmacy compounding activities only

Correct Answer: To ensure drugs are consistently produced and controlled to meet safety, identity, strength, quality, and purity requirements

Q2. Which part of the US cGMP regulations specifically contains detailed requirements for finished pharmaceuticals (finished dosage forms)?

• 21 CFR Part 210
• 21 CFR Part 211
• 21 CFR Part 600
• 21 CFR Part 11

Correct Answer: 21 CFR Part 211

Q3. Under cGMP, who is ultimately responsible for establishing and maintaining procedures and practices to ensure compliance within a manufacturing firm?

• The Quality Control analyst on each shift
• The owner, operator, or agent in charge of the establishment
• The contract laboratory performing finished product testing
• The packaging material vendor

Correct Answer: The owner, operator, or agent in charge of the establishment

Q4. Which of the following is a core responsibility of the Quality Unit as defined in cGMP?

• Performing only routine maintenance on equipment
• Approving or rejecting all materials, processes, and finished product batches
• Marketing and distribution of released batches
• Setting retail prices for the product

Correct Answer: Approving or rejecting all materials, processes, and finished product batches

Q5. The Master Production and Control Record (master batch record) must include which of the following elements?

• Only the recipe without in-process tests or packaging instructions
• Complete manufacturing instructions, specifications, labeling, sampling and testing procedures, and processing steps
• Marketing plans and promotional materials
• Only the identity of raw material suppliers

Correct Answer: Complete manufacturing instructions, specifications, labeling, sampling and testing procedures, and processing steps

Q6. Which information is required to be recorded in the Batch Production Record (BPR) for each production lot?

• Planned yield only, without actual yields or operator signatures
• Actual quantities used, actual yields, in-process data, and signatures of responsible personnel
• Only the final product release date
• Marketing approval letters from distributors

Correct Answer: Actual quantities used, actual yields, in-process data, and signatures of responsible personnel

Q7. According to 21 CFR Part 211, production and control records must be retained for what minimum period?

• 6 months after final distribution of the lot
• 1 year after the expiration date, or if no expiration date, 3 years after distribution of the last lot
• Indefinitely, at the company’s discretion
• Only until the next FDA inspection

Correct Answer: 1 year after the expiration date, or if no expiration date, 3 years after distribution of the last lot

Q8. How must an expiration dating period for a finished drug product be established under cGMP?

• By copying the supplier’s expiration period without testing
• Based on scientific stability studies demonstrating product remains within specification under labeled storage conditions
• Arbitrarily assigned by marketing based on projected sales
• Using the earliest expiry of any single raw material

Correct Answer: Based on scientific stability studies demonstrating product remains within specification under labeled storage conditions

Q9. Under US law, a drug manufactured without adherence to cGMP is generally considered:

• Misbranded
• Adulterated
• Approved for export only
• Exempt from inspection

Correct Answer: Adulterated

Q10. When is cleaning validation required according to cGMP principles?

• Only when the same equipment is used for formulation and packaging
• When residues or cross-contamination could affect product safety, efficacy, or quality
• Never, visual inspection is always sufficient
• Only for biologic manufacturing, not for small-molecule drugs

Correct Answer: When residues or cross-contamination could affect product safety, efficacy, or quality

Q11. Environmental and personnel monitoring is mandatory in which manufacturing area under cGMP?

• All areas are exempt from environmental monitoring
• Sterile manufacturing and any area where contamination could affect product quality
• Only in storage warehouses
• Only in administrative offices

Correct Answer: Sterile manufacturing and any area where contamination could affect product quality

Q12. Before labels are issued for use in packaging operations, cGMP requires:

• Labels may be used without oversight if packaging is automated
• Reconciliation of label quantities and approval by the responsible unit (e.g., Quality Unit)
• Labels should be destroyed immediately after printing
• Labels can be copied from previous lots without verification

Correct Answer: Reconciliation of label quantities and approval by the responsible unit (e.g., Quality Unit)

Q13. Representative sampling for finished product testing should ensure what under cGMP?

• That only one unit per lot is tested to save cost
• That samples are representative of the entire lot and adequate for statistically sound testing of identity, strength, quality, and purity
• That samples are taken only from the first package produced
• That only visual inspection is performed for quality assessment

Correct Answer: That samples are representative of the entire lot and adequate for statistically sound testing of identity, strength, quality, and purity

Q14. When unexplained discrepancies or failures of a batch occur, cGMP requires:

• Immediate release of the batch if the deviation is minor
• Thorough investigation, documentation, and disposition decision by the Quality Unit
• Destruction without investigation
• Notification of marketing team first for commercial assessment

Correct Answer: Thorough investigation, documentation, and disposition decision by the Quality Unit

Q15. Written procedures (SOPs) are required under cGMP for which activities?

• Only for laboratory testing
• For all operations that can affect the identity, strength, quality, or purity of the drug, including manufacturing, packaging, and laboratory operations
• Only for executive management
• Only for cleaning activities outside production areas

Correct Answer: For all operations that can affect the identity, strength, quality, or purity of the drug, including manufacturing, packaging, and laboratory operations

Q16. Under cGMP, changes that may affect product quality must be:

• Implemented immediately and documented later
• Evaluated, documented, and approved before implementation through formal change control
• Communicated only to production staff without documentation
• Decided by sales department based on demand

Correct Answer: Evaluated, documented, and approved before implementation through formal change control

Q17. Reserve (retention) samples of finished lots should be retained for what purpose and period under 21 CFR Part 211?

• For promotional use, retained permanently
• To permit future testing in the event of complaints or investigation; retained 1 year after expiration or 3 years if no expiration
• Only until the next production run is completed
• To be returned to the supplier after six months

Correct Answer: To permit future testing in the event of complaints or investigation; retained 1 year after expiration or 3 years if no expiration

Q18. How should returned or salvaged drug products that were previously distributed be handled according to cGMP?

• They may be reintroduced into stock immediately
• They must be quarantined, evaluated, and dispositioned by the Quality Unit before any reissue
• They must be destroyed by the shipping department without documentation
• They should be given to staff as samples

Correct Answer: They must be quarantined, evaluated, and dispositioned by the Quality Unit before any reissue

Q19. Personnel training under cGMP must include which of the following?

• Only job-specific skills, not cGMP concepts
• Training in cGMP principles, hygiene, sanitation, and procedures relevant to their duties, with records maintained
• Training only if hired from another country
• Training delegated entirely to external consultants with no records

Correct Answer: Training in cGMP principles, hygiene, sanitation, and procedures relevant to their duties, with records maintained

Q20. During an FDA inspection for cGMP compliance, the agency has the authority to do which of the following?

• Inspect facilities, review and copy production and control records, and take samples
• Seize shipments without legal basis and ignore records
• Terminate company operations permanently without notice
• Modify company SOPs on site

Correct Answer: Inspect facilities, review and copy production and control records, and take samples

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