Release procedures for finished products MCQs With Answer

Introduction: Release procedures for finished products are a critical part of Quality Control and Quality Assurance in pharmaceutical manufacturing. This quiz collection for M.Pharm students focuses on principles and practical aspects of releasing batches for distribution, including documentation review, analytical and microbiological testing, stability considerations, sampling plans, quarantine, hold-and-release criteria, and handling out-of-specification (OOS) results. Emphasis is placed on the roles and responsibilities of QA/QC, Certificate of Analysis (CoA) content, retention samples, reprocessing/rework, and regulatory expectations such as parametric release and batch record review. These MCQs are designed to deepen understanding and prepare students for real-world decision-making in final product release.

Q1. Which activity is the primary responsibility of Quality Assurance before a finished product batch is released?

• Performing all analytical tests on release samples
• Reviewing the batch manufacturing and testing records to ensure compliance
• Packaging the final product
• Transporting the batch to distribution centers

Correct Answer: Reviewing the batch manufacturing and testing records to ensure compliance

Q2. What is the purpose of placing a finished batch in quarantine?

• To allow the product to age before sale
• To prevent release until all required tests and documentation are satisfactorily completed
• To store excess inventory due to overproduction
• To prepare the batch for export only

Correct Answer: To prevent release until all required tests and documentation are satisfactorily completed

Q3. Which document typically contains the results and acceptance criteria used to approve a finished product batch for release?

• Master Production Schedule
• Certificate of Analysis (CoA)
• Purchase Order
• Maintenance Log

Correct Answer: Certificate of Analysis (CoA)

Q4. When should stability data be considered for release of a new drug product batch?

• Only after one year of marketed use
• When initial accelerated and short-term real-time data support shelf-life assignment or when provisional/commitment stability data are available
• Stability data are irrelevant to initial batch release
• Only when a product is exported to countries requiring stability reports

Correct Answer: When initial accelerated and short-term real-time data support shelf-life assignment or when provisional/commitment stability data are available

Q5. What is the typical minimum requirement for retention samples of finished product in many regulatory guidelines?

• No retention samples are required
• Retention samples should be kept until the batch is sold out
• Retention samples should be retained for at least the shelf-life of the product plus one year or as per local regulation
• Retention samples are discarded after stability testing

Correct Answer: Retention samples should be retained for at least the shelf-life of the product plus one year or as per local regulation

Q6. Which action is appropriate when a finished product test result is out-of-specification (OOS)?

• Ignore the OOS and release the batch to avoid delays
• Immediately release the batch pending review
• Initiate an investigation, perform retests as justified, and document a full OOS investigation before any release decision
• Re-label the batch with a later expiry date

Correct Answer: Initiate an investigation, perform retests as justified, and document a full OOS investigation before any release decision

Q7. Parametric release applies primarily to which category of products?

• Topical creams only
• Terminally sterilized products where validated in-process and environmental parameters can substitute for routine sterility testing
• Any non-sterile oral solid dosage forms
• Products requiring cold chain distribution only

Correct Answer: Terminally sterilized products where validated in-process and environmental parameters can substitute for routine sterility testing

Q8. Which of the following is NOT a standard element in a batch release record review?

• Verification that critical process parameters were within limits
• Confirmation of packaging component identity and reconciliation
• Review of deviations, investigations and CAPA related to the batch
• Detailed marketing strategy and pricing plan

Correct Answer: Detailed marketing strategy and pricing plan

Q9. What is label reconciliation during finished product release?

• Counting and matching labels issued for a batch to the quantity of produced units to ensure no excess or missing labels
• Updating the label artwork for a new market
• Designing labels for future production
• Re-labeling expired stock for internal use

Correct Answer: Counting and matching labels issued for a batch to the quantity of produced units to ensure no excess or missing labels

Q10. Which microbial test is most critical for the release of sterile injectable products?

• Total viable count for non-sterile products
• Sterility testing
• Antimicrobial effectiveness testing
• Endotoxin test only

Correct Answer: Sterility testing

Q11. What is the role of a Qualified Person (QP) or responsible reviewer in batch release in many regulatory systems?

• To perform analytical testing personally for every batch
• To provide independent certification that each batch has been manufactured and tested in accordance with approved procedures and is fit for release
• To handle distribution logistics
• To set the product price

Correct Answer: To provide independent certification that each batch has been manufactured and tested in accordance with approved procedures and is fit for release

Q12. Which practice is acceptable when a minor non-conformance is identified in the batch record but does not affect product quality?

• Release without documentation because it is minor
• Document the non-conformance, assess impact, approve with justification and corrective actions before release
• Destroy the entire batch immediately
• Change the batch record to remove the non-conformance

Correct Answer: Document the non-conformance, assess impact, approve with justification and corrective actions before release

Q13. Which of the following best describes Out-of-Trend (OOT) results in the context of release testing?

• Results that are within specification limits but show an unexpected trend compared to historical data and may need investigation
• Results that are clearly outside specification and require immediate rejection
• Results that confirm the product is better than previous batches
• Results that are irrelevant to release decisions

Correct Answer: Results that are within specification limits but show an unexpected trend compared to historical data and may need investigation

Q14. Which element is essential on a Certificate of Analysis (CoA) for a finished product?

• Supplier bank details
• List of all employees involved in manufacturing
• Test results for specified quality attributes and statement of conformity to release specifications
• Marketing claim endorsements

Correct Answer: Test results for specified quality attributes and statement of conformity to release specifications

Q15. When can reprocessing or rework of a finished pharmaceutical product batch be considered?

• Whenever production is behind schedule
• Only when pre-approved procedures exist, product quality is not compromised, and regulatory and documentation requirements are met
• Reprocessing is never allowed under any circumstances
• When labels are missing, without any authorization

Correct Answer: Only when pre-approved procedures exist, product quality is not compromised, and regulatory and documentation requirements are met

Q16. Which sampling plan concept is commonly used for finished product release inspections?

• Arbitrary sampling with no statistical basis
• Acceptance Quality Limit (AQL) based sampling to balance lot acceptance risk
• Sampling only one unit per batch regardless of size
• Sampling only after distribution

Correct Answer: Acceptance Quality Limit (AQL) based sampling to balance lot acceptance risk

Q17. What should QA do if a critical deviation affecting sterility assurance is discovered after product release?

• Nothing, because the batch is already released
• Initiate recall or market withdrawal if risk assessment indicates potential patient impact, and perform root cause analysis and corrective actions
• Change the product label to remove sterility claims
• Delay any action until the next regulatory inspection

Correct Answer: Initiate recall or market withdrawal if risk assessment indicates potential patient impact, and perform root cause analysis and corrective actions

Q18. Which of the following is a key consideration when approving accelerated release based on a stability commitment?

• There is never any justification for accelerated release
• Robust initial stability data, a documented commitment to continue long-term stability studies, and risk mitigation measures are in place
• Only the marketing department approval is needed
• Accelerated release is permitted without any documentation if sales demand is high

Correct Answer: Robust initial stability data, a documented commitment to continue long-term stability studies, and risk mitigation measures are in place

Q19. Which test is typically required for parenteral products as part of release testing to detect pyrogenic substances?

• pH only
• Bacterial endotoxin test (BET) or Limulus Amoebocyte Lysate (LAL) test
• Disintegration test
• Friability test

Correct Answer: Bacterial endotoxin test (BET) or Limulus Amoebocyte Lysate (LAL) test

Q20. During final product release, why is reconciliation of bulk to finished quantities important?

• To verify that the packaging line is operating at maximum speed
• To ensure the number of finished units produced matches inputs and labels used, detecting losses, overfills, or potential diversion
• To calculate marketing margins
• To determine employee productivity bonuses

Correct Answer: To ensure the number of finished units produced matches inputs and labels used, detecting losses, overfills, or potential diversion

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