Inspection of drug products MCQs With Answer

Introduction:
This collection of MCQs on the inspection of drug products is designed specifically for M.Pharm students preparing for advanced exams in Quality Control & Quality Assurance. It focuses on practical and regulatory aspects of visual and instrumental inspection, container-closure integrity, particulate control, sampling/sampling plans, defect classification, and investigation of non-conformities. Questions probe critical decision points encountered during batch release and regulatory inspections, emphasizing standards and methods such as USP/ICH guidelines, statistical sampling, and sterility-related inspection practices. Use these MCQs to test knowledge, identify gaps, and sharpen inspection skills essential for ensuring product quality and patient safety in pharmaceutical manufacturing.

Q1. What is the primary purpose of visual inspection of finished drug products?

• To determine chemical potency of active ingredients
• To detect visible defects such as particulates, discoloration, cracks and label errors
• To measure moisture content of the product
• To perform sterility testing

Correct Answer: To detect visible defects such as particulates, discoloration, cracks and label errors

Q2. Which sampling approach is commonly applied to lot release inspections in pharmaceutical manufacturing?

• 100% destructive testing of all units in the lot
• Statistical sampling based on an acceptable quality level (AQL)
• Random single-unit inspection without plan
• Only testing the first and last unit of the lot

Correct Answer: Statistical sampling based on an acceptable quality level (AQL)

Q3. For parenteral products, which inspection methods are considered acceptable for detecting visible particulates?

• Manual visual inspection only, automated systems are not allowed
• Automated inspection only, manual inspection is obsolete
• Both manual (trained operators) and automated machine vision systems depending on volume and risk
• Only final chemical assays can confirm particulate presence

Correct Answer: Both manual (trained operators) and automated machine vision systems depending on volume and risk

Q4. In which ISO/Class environment should visual inspection of aseptically filled sterile injectables ideally be performed?

• ISO 8 (Grade D)
• ISO 7 (Grade C)
• ISO 5 (Grade A) with appropriate background Grade B conditions
• Any room as long as operators are trained

Correct Answer: ISO 5 (Grade A) with appropriate background Grade B conditions

Q5. Which of the following defect types would typically be classified as “critical” during product inspection?

• Minor printer smudge on secondary carton
• Discolored outer carton due to ink variation
• Cracked vial or compromised container-closure integrity exposing sterility risk
• Small, non-functional cosmetic scratch on packaging

Correct Answer: Cracked vial or compromised container-closure integrity exposing sterility risk

Q6. Why are black and white background panels and oblique illumination used in manual visual inspection stations?

• To improve operator comfort only
• To make labels look better for photography
• To enhance contrast for detection of both color and transparent particulates and surface defects
• To sterilize the inspection area with light

Correct Answer: To enhance contrast for detection of both color and transparent particulates and surface defects

Q7. Which performance parameters are critical when validating automated machine-vision inspection systems?

• Packaging color only
• Detection probability (sensitivity), false reject rate, and false accept rate (specificity)
• Battery life of the camera
• Inventory levels in warehouse

Correct Answer: Detection probability (sensitivity), false reject rate, and false accept rate (specificity)

Q8. Which container-closure integrity (CCI) method is regarded as one of the most sensitive for detecting very small leaks in parenteral containers?

• Dye ingress with methylene blue only
• Visual inspection under magnification
• Helium leak detection (tracer gas leak test)
• Simple pressure testing with water immersion only

Correct Answer: Helium leak detection (tracer gas leak test)

Q9. Which USP chapter primarily addresses subvisible particulate matter limits for injection products?

• USP <1010>
• USP <788>
• USP <821>
• USP <900>

Correct Answer: USP <788>

Q10. Upon obtaining an out-of-specification (OOS) result during finished-product inspection, what is the correct immediate action?

• Discard the result and retest repeatedly until passing
• Release the batch if most units pass
• Quarantine the lot, initiate formal investigation, document procedures and root cause before any retest
• Ignore and continue with next batch

Correct Answer: Quarantine the lot, initiate formal investigation, document procedures and root cause before any retest

Q11. For parenteral products intended for intravenous use, what is the industry expectation regarding visual inspection coverage?

• No inspection is required if sterility tests passed
• 100% visual inspection is expected (manual or automated) for detection of visible defects prior to release
• Inspect only a statistical sample of 1% of units
• Inspect only the first 10 units from each batch

Correct Answer: 100% visual inspection is expected (manual or automated) for detection of visible defects prior to release

Q12. What key elements are examined when assessing tamper-evident features during packaging inspection?

• Product potency and dissolution only
• Integrity of seals, presence and condition of shrink bands, breakable seals, and security labels
• Vehicle mileage of distribution transport
• Color of the printed leaflet

Correct Answer: Integrity of seals, presence and condition of shrink bands, breakable seals, and security labels

Q13. What is the correct procedure for returned goods suspected to be compromised?

• Redistribute them after simple re-labelling
• Quarantine the returned items and perform a formal QA evaluation including investigation, testing and disposition decision
• Dispose immediately without documentation
• Put them back on the shelf for sale

Correct Answer: Quarantine the returned items and perform a formal QA evaluation including investigation, testing and disposition decision

Q14. Which ICH guideline covers photostability testing and is relevant when inspecting packaging for light-sensitive products?

• ICH Q3A
• ICH Q1B
• ICH Q6A
• ICH M4

Correct Answer: ICH Q1B

Q15. What is the primary rationale for performing a weight variation test on tablets during inspection?

• To estimate tablet color consistency
• To assess uniformity of mass as an indirect indicator of content uniformity and manufacturing consistency
• To measure crushing strength directly
• To determine moisture adsorption only

Correct Answer: To assess uniformity of mass as an indirect indicator of content uniformity and manufacturing consistency

Q16. During packaging for blinded clinical trials, what inspection focus ensures integrity of blinding?

• Ensure randomization codes are printed on the outside of primary pack
• Verify that labels and secondary packaging do not reveal treatment allocation and that code linkage is secure
• Ensure placebo is visually distinguishable from active product
• Confirm unblinded treatment is used for all subjects

Correct Answer: Verify that labels and secondary packaging do not reveal treatment allocation and that code linkage is secure

Q17. Which of the following lists contains commonly used container-closure integrity (CCI) test methods?

• pH measurement, melting point, and refractive index
• Dye ingress, vacuum/pressure decay, and tracer gas (helium) leak test
• Visual color matching only
• Microbial culturing of external surfaces only

Correct Answer: Dye ingress, vacuum/pressure decay, and tracer gas (helium) leak test

Q18. USP <788> specifies subvisible particle counts for two particle sizes used during inspection. Which sizes are these?

• >=1 µm and >=5 µm
• >=10 µm and >=25 µm
• >=50 µm and >=100 µm
• >=0.1 µm and >=0.5 µm

Correct Answer: >=10 µm and >=25 µm

Q19. If an inspection shows a defect rate higher than the established acceptance number from the sampling plan, the immediate GMP-compliant action is:

• Release the lot after a superficial cleaning
• Accept the lot and update the sampling plan later
• Reject or quarantine the lot and initiate a formal investigation and corrective actions (CAPA)
• Burn the inspection records and restart

Correct Answer: Reject or quarantine the lot and initiate a formal investigation and corrective actions (CAPA)

Q20. During a regulatory inspection of finished product release, which areas receive high focus and scrutiny from inspectors?

• Only cafeteria hygiene
• Data integrity, batch records, deviation/OOS investigations, QA oversight and compliance with GMP
• Only parking facilities for staff
• Marketing brochures and sales pitches

Correct Answer: Data integrity, batch records, deviation/OOS investigations, QA oversight and compliance with GMP

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