Charge-in of components and material management MCQs With Answer

Introduction

The following quiz collection focuses on charge‑in of components and material management — a critical area of Quality Control & Quality Assurance for M.Pharm students. These MCQs cover practical and regulatory aspects such as component release, quarantine, identity checks, weighment procedures, overages, documentation and reconciliation, sampling and return-to-stock procedures, and electronic batch record implications. Questions are designed to probe understanding of GMP requirements, SOP adherence, traceability, and risk controls applied during charging and material handling in manufacturing. Use these to test deeper conceptual knowledge as well as operational decision‑making you will need in real-world pharmaceutical manufacturing and QC/QA functions.

Q1. What is the primary purpose of the “charge‑in” step in pharmaceutical manufacturing?

• To physically add and document components into the batch record during production
• To perform final release testing of the finished product
• To transport finished goods to the warehouse
• To clean and sterilize production equipment before use

Correct Answer: To physically add and document components into the batch record during production

Q2. Which department must normally release raw materials before they can be charged into a batch?

• Production supervision
• Quality Control (QC)
• Material handling
• Warehouse receiving only

Correct Answer: Quality Control (QC)

Q3. What does a “quarantined” status mean for a component intended for charge‑in?

• The component is approved for immediate use
• The component is under investigation or awaiting QC release and not for use
• The component is expired and must be destroyed
• The component can be used for non‑commercial trials only

Correct Answer: The component is under investigation or awaiting QC release and not for use

Q4. What is the minimum identity check requirement prior to charging a component?

• Verify container color matches previous batch
• Match the material label to the master batch record and the approved Certificate of Analysis (CoA)
• Confirm expiry date only
• Weigh the material without checking label information

Correct Answer: Match the material label to the master batch record and the approved Certificate of Analysis (CoA)

Q5. How should weighment tolerances for critical components be established?

• Use a fixed ±50% tolerance for all components
• As defined in the approved master formula/SOP and based on risk assessment and analytical balance capability
• Allow any deviation if final product meets specification
• Set tolerances arbitrarily during production

Correct Answer: As defined in the approved master formula/SOP and based on risk assessment and analytical balance capability

Q6. What is the purpose of adding an “overage” for certain components during charge‑in?

• To intentionally increase potency beyond specification
• To compensate for expected losses during processing so the final product meets target specification
• To reduce manufacturing costs
• To extend shelf life of the finished product

Correct Answer: To compensate for expected losses during processing so the final product meets target specification

Q7. When performing weighment, what does “tare” refer to?

• The gross weight including container and contents
• The weight of the empty container which must be subtracted to obtain net material weight
• The total target batch weight
• A method of material sampling

Correct Answer: The weight of the empty container which must be subtracted to obtain net material weight

Q8. Material reconciliation after charge‑in should compare which of the following?

• Theoretical usage from master formula versus actual quantity consumed and returned
• Only the number of containers used versus ordered
• The supplier invoice value against production costs
• The number of personnel involved in charging

Correct Answer: Theoretical usage from master formula versus actual quantity consumed and returned

Q9. If an incorrect component is discovered already charged into the batch, what is the immediate action?

• Continue production and correct at the next stage
• Stop the process, isolate the batch, notify QA and QC, and document the deviation
• Substitute the component with a similar one without documentation
• Mix additional correct component to dilute the error

Correct Answer: Stop the process, isolate the batch, notify QA and QC, and document the deviation

Q10. Which role is primarily responsible for ensuring material availability, traceability and documentation during charge‑in?

• Laboratory technician
• Material/warehouse manager in coordination with QA
• Marketing manager
• External courier service

Correct Answer: Material/warehouse manager in coordination with QA

Q11. What information should the Master Batch Record (MBR) specify about charge‑in?

• Only the name of the product
• Detailed sequence of charging, quantities, tolerances, equipment, and any special handling instructions
• Warehouse storage locations unrelated to production
• Supplier pricing and payment terms

Correct Answer: Detailed sequence of charging, quantities, tolerances, equipment, and any special handling instructions

Q12. What does “chain of custody” documentation during material movement ensure?

• That materials are attractive in packaging
• Traceability of who moved or handled the material, when and why, preserving integrity and accountability
• Lowering raw material costs
• Accelerated shelf‑life assignment

Correct Answer: Traceability of who moved or handled the material, when and why, preserving integrity and accountability

Q13. How is the shelf‑life/retest date of a component generally determined for use in charge‑in decisions?

• Based on supplier recommendation alone without QC review
• As defined by supplier/manufacturer and confirmed by QC at release; effective life calculated from manufacture or retest date per specification
• Always set to two years regardless of data
• From the date of first use in production

Correct Answer: As defined by supplier/manufacturer and confirmed by QC at release; effective life calculated from manufacture or retest date per specification

Q14. What is an appropriate practice for sampling a component prior to charge‑in?

• Random sampling without record keeping
• Sampling according to an approved sampling plan with documented procedures and traceable sample IDs
• Sampling only from the top layer of the container without agitation
• No sampling is required if label looks correct

Correct Answer: Sampling according to an approved sampling plan with documented procedures and traceable sample IDs

Q15. For critical or potent APIs, what additional control is commonly required during weighment and charge‑in?

• No special control beyond normal PPE
• Independent double‑check by a second qualified person and dedicated containment/PPE
• Weighing in the main corridor to improve ventilation
• Using approximate visual estimation to save time

Correct Answer: Independent double‑check by a second qualified person and dedicated containment/PPE

Q16. What is a key advantage of using Electronic Batch Records (EBR) for material charge‑in?

• They eliminate the need for any operator training
• Real‑time traceability, automatic time stamps, reduced transcription errors and audit trail for material movements
• They make manual traceability impossible
• EBRs remove the need for QC release

Correct Answer: Real‑time traceability, automatic time stamps, reduced transcription errors and audit trail for material movements

Q17. Which detail is essential on labels of materials issued to production?

• Supplier invoice number only
• Material name, manufacturer, lot/batch number, quantity issued, and intended production batch reference
• Name of the production operator only
• Company logo without any batch information

Correct Answer: Material name, manufacturer, lot/batch number, quantity issued, and intended production batch reference

Q18. If unused material is returned from production to the warehouse, what must be done before it can be reused?

• Immediately reuse without documentation
• Quarantine and disposition by QC/QA, including re‑sampling and verification or disposal decision
• Mix it into another batch
• Discard it without review

Correct Answer: Quarantine and disposition by QC/QA, including re‑sampling and verification or disposal decision

Q19. Why is appropriate PPE and gowning required during charge‑in operations?

• Only to conform to fashion standards
• To protect product from contamination and protect personnel from exposure to hazardous materials
• PPE is optional if the area looks clean
• To increase the speed of charging operations

Correct Answer: To protect product from contamination and protect personnel from exposure to hazardous materials

Q20. What information is typically recorded on a weighment slip used during charge‑in?

• Only the name of the material
• Net weight, tare container weight, balance identification, operator initials, date/time and reference to batch/MBR
• The supplier’s marketing brochure
• Only the final product expiry date

Correct Answer: Net weight, tare container weight, balance identification, operator initials, date/time and reference to batch/MBR

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