Processing of intermediates and bulk products MCQs With Answer

Introduction: Processing of intermediates and bulk products is a crucial module for M.Pharm students specializing in Quality Control & Quality Assurance. This set of MCQs focuses on GMP-compliant handling, in-process controls, sampling, testing, hold-time, segregation, rework/reprocessing, yield reconciliation, and documentation practices specific to intermediates and bulk drug substances. Questions cover analytical and operational considerations such as stability of intermediates, residual solvent limits, microbial contamination control, packaging of bulk material, and release criteria. These items are designed to deepen understanding, reinforce regulatory expectations, and prepare students for practical QA/QC challenges encountered in pharmaceutical manufacturing and regulatory inspections.

Q1. Which practice is essential to prevent cross-contamination during processing of API intermediates in a multi-product facility?

• Using the same equipment sequentially with visual cleaning only
• Scheduling products with highest toxicological risk last
• Relying solely on operator judgment for cleanliness
• Performing unvalidated manual cleaning between batches

Correct Answer: Scheduling products with highest toxicological risk last

Q2. What is the primary purpose of defining hold times for intermediates?

• To reduce process cycle time irrespective of stability
• To determine when the final product must be shipped
• To ensure intermediate stability and prevent degradation before further processing
• To avoid cleaning validation

Correct Answer: To ensure intermediate stability and prevent degradation before further processing

Q3. During bulk product release, which documentation is critical to demonstrate batch-to-batch consistency?

• Operator training certificates only
• Batch manufacturing records and analytical release data
• Purchase orders for raw materials only
• Maintenance logs of unrelated equipment

Correct Answer: Batch manufacturing records and analytical release data

Q4. What is an appropriate in-process control for a wet granulation step producing an intermediate?

• Measuring particle size distribution and moisture content
• Only recording time of day
• Checking packaging label colour
• Confirming operator breaks were taken

Correct Answer: Measuring particle size distribution and moisture content

Q5. Which criterion determines whether an intermediate can be released for further processing without full stability data?

• Manufacturer’s promotional claims
• Validated hold-time studies and supported stability-indicating data
• Length of manufacturing shift
• Price of the intermediate

Correct Answer: Validated hold-time studies and supported stability-indicating data

Q6. In bulk product sampling, what principle must be followed to obtain representative samples?

• Sampling only from the top layer of the container
• Using a statistically justified sampling plan (random and composite sampling)
• Sampling based on operator convenience
• Always using the first container available

Correct Answer: Using a statistically justified sampling plan (random and composite sampling)

Q7. Which analytical test is most important to detect degradation products in intermediates prior to final processing?

• Color comparison against a vendor photograph
• Stability-indicating HPLC method with appropriate validation
• Simple pH strip test only
• Thermometer reading

Correct Answer: Stability-indicating HPLC method with appropriate validation

Q8. What is the regulatory expectation when bulk intermediates are quarantined pending release testing?

• They can be used at the operator’s discretion
• They must be physically segregated, labelled as quarantine, and inaccessible for use
• They require no documentation
• They should be stored next to released material

Correct Answer: They must be physically segregated, labelled as quarantine, and inaccessible for use

Q9. Which approach is appropriate for reconciliation of yield for an intermediate batch?

• Ignoring expected loss and reporting only theoretical yield
• Recording theoretical yield, actual yield, and explaining variances with calculations
• Estimating losses without documenting measurements
• Reporting the highest possible yield to management

Correct Answer: Recording theoretical yield, actual yield, and explaining variances with calculations

Q10. When is reprocessing or reworking of an intermediate acceptable under GMP?

• When it is described in an approved procedure and does not adversely affect quality
• Any time the production team decides it is faster
• Only if the product is already released
• When it reduces costs regardless of validation

Correct Answer: When it is described in an approved procedure and does not adversely affect quality

Q11. For control of residual solvents in a bulk intermediate, which guideline is commonly referenced?

• ICH Q3C limits for residual solvents
• EPA drinking water standards
• Food additive regulations
• Pharmacopoeial viscosity criteria

Correct Answer: ICH Q3C limits for residual solvents

Q12. What is the best practice for labelling bulk containers of intermediates during processing?

• Hand-written temporary labels without batch information
• Clear, durable labels containing batch number, status (quarantine/release), product name, and expiry/hold time
• Only the operator’s initials
• Labels with marketing slogans

Correct Answer: Clear, durable labels containing batch number, status (quarantine/release), product name, and expiry/hold time

Q13. Which environmental control is most critical for processing sterile intermediates or bulk sterile drug substances?

• Controlled particle counts and viable microbial monitoring in classified cleanrooms
• Ambient office air monitoring
• Outdoor humidity readings
• Sound level monitoring

Correct Answer: Controlled particle counts and viable microbial monitoring in classified cleanrooms

Q14. In the context of intermediate testing, what does a validated ID test ensure?

• That the sample meets dissolution requirements
• Accurate and specific identification of the chemical entity without interference
• That the product is sterile
• Only the colour is correct

Correct Answer: Accurate and specific identification of the chemical entity without interference

Q15. Which action is required when an out-of-specification (OOS) result is obtained on a bulk intermediate?

• Release the batch if production needs demand it
• Initiate an OOS investigation per written procedures and hold the material
• Ignore the result and retest once without investigation
• Discard the investigation paperwork

Correct Answer: Initiate an OOS investigation per written procedures and hold the material

Q16. What is the role of a stability-indicating method for intermediates?

• To quantify only the active pharmaceutical ingredient regardless of impurities
• To detect and quantify degradation products and ensure method specificity under stress conditions
• To replace cleaning validation
• To assess colour uniformity only

Correct Answer: To detect and quantify degradation products and ensure method specificity under stress conditions

Q17. For large-volume bulk solids, which sampling technique reduces segregation bias?

• Taking a single top-layer scoop
• Composite sampling by incremental sampling across depths and positions
• Sampling only from the discharge point
• Sampling only from corners of the container

Correct Answer: Composite sampling by incremental sampling across depths and positions

Q18. Which consideration is important when transferring intermediates between sites?

• Assuming identical environmental conditions at both sites
• Establishing transfer agreements, change control, stability bridging and transport conditions
• Releasing material at origin without any testing at destination
• Transporting without validated packaging

Correct Answer: Establishing transfer agreements, change control, stability bridging and transport conditions

Q19. What is the function of in-process documentation (IPR) during bulk product manufacture?

• To provide traceability of process parameters, deviations, and batch-specific data for quality assurance
• To serve as a marketing brochure
• To record only the final release result
• To replace validated analytical methods

Correct Answer: To provide traceability of process parameters, deviations, and batch-specific data for quality assurance

Q20. Which parameter is most useful to monitor during drying of an intermediate to ensure consistent quality?

• Operator shoe size
• Moisture content (e.g., loss on drying) and drying endpoint validation
• Colour of the drying room walls
• Time of day only

Correct Answer: Moisture content (e.g., loss on drying) and drying endpoint validation

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