USFDA cGMP (CDER & CBER) requirements MCQs With Answer

Introduction

This quiz collection on USFDA cGMP (CDER & CBER) requirements is tailored for M.Pharm students preparing for exams and industry roles in quality assurance and quality control. The questions cover critical regulatory expectations from the Code of Federal Regulations and FDA guidance—focusing on drug (CDER) and biologic/blood products (CBER) manufacturing. Topics include responsibility of the Quality Unit, documentation and records, aseptic processing, sterility and endotoxin testing, validation, stability, investigations, change control, recalls, and biologics-specific controls like potency, donor screening, and viral safety. Use these MCQs to test conceptual understanding and practical application of cGMP requirements essential for regulatory compliance in pharmaceutical manufacturing.

Q1. Under 21 CFR 211, which unit is primarily responsible for approving or rejecting components, drug product containers, and in-process materials?

• Production Department
• Quality Unit
• Regulatory Affairs
• Research & Development

Correct Answer: Quality Unit

Q2. Which CFR parts primarily contain cGMP requirements specifically applicable to biological products regulated by CBER?

• 21 CFR Parts 210–211
• 21 CFR Parts 600–680
• 21 CFR Part 820
• 21 CFR Parts 100–199

Correct Answer: 21 CFR Parts 600–680

Q3. According to cGMP, what is the primary purpose of a Master Production Record (MPR)?

• To list vendor contact details
• To describe packaging artwork only
• To provide a complete history and standardized instructions for manufacturing each product batch
• To record employee training schedules

Correct Answer: To provide a complete history and standardized instructions for manufacturing each product batch

Q4. Which of the following is the FDA-recommended initial action when an OOS (Out of Specification) result is obtained for a release test?

• Automatically discard the batch
• Issue a recall immediately
• Initiate a formal OOS investigation and hold the batch pending investigation
• Retest without documented investigation

Correct Answer: Initiate a formal OOS investigation and hold the batch pending investigation

Q5. For sterile drug products, which environmental qualification is essential for aseptic processing areas to minimize contamination risk?

• Positive pressure gradient and HEPA-filtered air
• High humidity without filtration
• Negative pressure relative to adjacent areas
• Unfiltered recirculated air

Correct Answer: Positive pressure gradient and HEPA-filtered air

Q6. What is a media fill (process simulation) intended to demonstrate in aseptic manufacturing?

• Chemical stability of the product
• Microbial growth potential of media components
• Aseptic process capability and operator/environmental aseptic performance
• Container-closure integrity only

Correct Answer: Aseptic process capability and operator/environmental aseptic performance

Q7. Which test is the USP-recommended compendial method for bacterial endotoxin detection in parenteral products?

• Sterility test (USP <71>)
• Limulus Amebocyte Lysate (LAL) test
• Gram staining
• pH measurement

Correct Answer: Limulus Amebocyte Lysate (LAL) test

Q8. According to ICH Q1A and cGMP expectations, what must a stability protocol define?

• Ingredients suppliers only
• Storage conditions, time points, testing parameters, and acceptance criteria
• Employee shift patterns
• Marketing strategies for shelf-life extension

Correct Answer: Storage conditions, time points, testing parameters, and acceptance criteria

Q9. Which procedure ensures documented control of changes that could affect product quality and regulatory compliance?

• Batch production records
• Change control
• Supplier audits
• Monthly sales reports

Correct Answer: Change control

Q10. What is the FDA Form 483 used for?

• To register a new manufacturing site
• To list product ingredients
• To document observations of nonconformances found during FDA inspections
• To authorize product labeling

Correct Answer: To document observations of nonconformances found during FDA inspections

Q11. Under CBER requirements, which control is especially critical for blood and blood-derived products?

• Stability at high temperature
• Donor screening, infectious disease testing, and traceability of donor to product
• Use of animal-derived excipients
• Commercial vendor marketing approvals

Correct Answer: Donor screening, infectious disease testing, and traceability of donor to product

Q12. Which document must contain a complete record of each batch’s manufacturing history, including deviations and signatures?

• Master Production Record (MPR)
• Batch Production Record (BPR)
• Purchase Order
• Equipment manual

Correct Answer: Batch Production Record (BPR)

Q13. What is the primary objective of validation in cGMP (e.g., process validation)?

• To document raw material suppliers
• To provide evidence that a process consistently produces a product meeting predetermined quality attributes
• To reduce production costs only
• To modify product formulation annually

Correct Answer: To provide evidence that a process consistently produces a product meeting predetermined quality attributes

Q14. Which action is required by cGMP when a product is found to present a serious risk to health after distribution?

• File an annual report only
• Initiate a recall and notify FDA as appropriate
• Destroy any remaining inventory silently
• Change the product label next production run

Correct Answer: Initiate a recall and notify FDA as appropriate

Q15. Under cGMP, what is the minimum expectation for retaining production and control records for finished drug products?

• One month
• At least 1 year after expiration date
• Retain for a period specified by regulation, typically at least 1 year after expiration or as required by CFR
• No retention required

Correct Answer: Retain for a period specified by regulation, typically at least 1 year after expiration or as required by CFR

Q16. Which of the following is a CBER-specific requirement for licensure/approval of some biological products?

• Clinical trials are optional
• Submission of potency assays and lot release testing data
• No requirement for cold chain documentation
• Only chemical tests are required

Correct Answer: Submission of potency assays and lot release testing data

Q17. What is the role of environmental monitoring (EM) in aseptic facilities under cGMP?

• To verify chemical compatibility of packaging
• To monitor viable and non-viable particulate levels and detect contamination trends
• To test marketing samples
• To calibrate production equipment

Correct Answer: To monitor viable and non-viable particulate levels and detect contamination trends

Q18. Which regulatory expectation applies to supplier qualification under cGMP?

• No supplier documentation is needed
• Manufacturers must evaluate and qualify suppliers and maintain records of supplier performance and change notifications
• Suppliers can be changed without notification
• Only price matters for supplier selection

Correct Answer: Manufacturers must evaluate and qualify suppliers and maintain records of supplier performance and change notifications

Q19. In investigating a contamination event, which of the following is a cGMP-required element?

• Perform root cause analysis, document corrective and preventive actions (CAPA), and verify effectiveness
• Ignore minor contamination if yield is acceptable
• Only inform marketing about delays
• Replace staff without investigation

Correct Answer: Perform root cause analysis, document corrective and preventive actions (CAPA), and verify effectiveness

Q20. Which reporting mechanism is typically used by manufacturers to report serious adverse events and product problems to the FDA?

• MedWatch (or equivalent adverse event reporting system)
• Monthly sales forecast
• Internal HR memo
• Annual manufacturing buffet

Correct Answer: MedWatch (or equivalent adverse event reporting system)

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