Blood and blood products: regulatory requirements and labelling (IN/US/EU) MCQs With Answer

Introduction

Understanding regulatory requirements and labeling for blood and blood products is essential for M.Pharm students specializing in regulatory affairs, biologics, or transfusion medicine. This quiz-oriented blog focuses on comparative regulations across India, the United States, and the European Union, covering licensing frameworks, quality systems, donor screening, testing, traceability, hemovigilance, storage conditions, and standardized labeling such as ISBT 128. The questions emphasize practical regulatory expectations—current good manufacturing practices, mandatory documentation, release criteria, and labelling particulars that ensure safety, efficacy, and traceability of blood components. Use these MCQs to reinforce knowledge required for inspections, submissions, and safe blood product handling in different regulatory jurisdictions.

Q1. Which regulatory instrument establishes EU-wide standards for the collection, testing, processing, storage and distribution of human blood and blood components?

• Directive 2002/98/EC (Blood Directive)
• Regulation (EC) No 726/2004
• ICH Q7 Good Manufacturing Practice
• US 21 CFR 606

Correct Answer: Directive 2002/98/EC (Blood Directive)

Q2. In the United States, which CFR part specifically sets out current good manufacturing practice (CGMP) requirements for establishments that collect and process blood and blood components?

• 21 CFR Part 312
• 21 CFR Part 606
• 21 CFR Part 820
• 21 CFR Part 210

Correct Answer: 21 CFR Part 606

Q3. In India, which authority is primarily responsible for national regulation and oversight of blood banks and blood products?

• Central Drugs Standard Control Organization (CDSCO)
• Pharmacopeia Commission of India
• National Accreditation Board for Testing and Calibration Laboratories (NABL)
• Food Safety and Standards Authority of India (FSSAI)

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q4. Which internationally accepted coding and labeling standard is widely used to ensure unique identification and traceability of blood units?

• GTIN Barcode Standard
• ISBT 128
• HL7 Version 2
• UDI-DI

Correct Answer: ISBT 128

Q5. Which of the following is a core labeling requirement for a donated blood unit in most regulatory frameworks (IN/US/EU)?

• Manufacturer’s marketing authorization number only
• Donation identification number, blood group, collection date and expiration
• Prescribing physician’s name and hospital invoice number
• Donor’s full residential address and telephone number

Correct Answer: Donation identification number, blood group, collection date and expiration

Q6. Which storage condition is generally required for red blood cell concentrates to maintain safety and quality?

• Room temperature (20–25°C)
• Deep freeze at ≤–80°C
• Refrigerated at 1–6°C
• Continuous warming at 37°C

Correct Answer: Refrigerated at 1–6°C

Q7. What regulatory concept requires blood establishments to maintain the ability to trace each donation from donor to recipient and vice versa?

• Good Clinical Practice (GCP)
• Traceability
• Bioequivalence
• Market exclusivity

Correct Answer: Traceability

Q8. Which of the following best describes the purpose of haemovigilance systems required by many jurisdictions?

• To manage financial reimbursement for transfusions
• To monitor, report and prevent adverse transfusion events and improve safety
• To increase blood donation drives and marketing
• To certify blood bank personnel qualifications

Correct Answer: To monitor, report and prevent adverse transfusion events and improve safety

Q9. Under EU rules, technical requirements for donor selection and testing are specified in which secondary legal act accompanying the Blood Directive?

• Commission Directive 2004/33/EC
• Directive 2010/63/EU
• Regulation 536/2014
• Decision 2005/…/EC

Correct Answer: Commission Directive 2004/33/EC

Q10. Which of the following tests is typically mandatory on all donated blood units in most regulatory systems before release for transfusion?

• HIV, Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, and Syphilis tests
• Liver function tests and kidney function tests
• Complete genomic sequencing
• Chest X-ray

Correct Answer: HIV, Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, and Syphilis tests

Q11. Which regulatory practice requires blood establishments to withhold distribution of a blood unit until required test results and defined release criteria are met?

• Quarantine and release
• Market authorization
• Batch pooling
• Compassionate use

Correct Answer: Quarantine and release

Q12. In the United States, what system or procedure is used to notify recipients who may have received blood from a donor later found to be infected?

• Lookback and notification procedures
• Unique Device Identification (UDI)
• Prescriber advisory bulletin
• Pharmacovigilance periodic report

Correct Answer: Lookback and notification procedures

Q13. Which quality system element is emphasized across IN/US/EU regulations for blood establishments to ensure consistent product quality?

• Current Good Manufacturing Practice (CGMP) and a documented quality management system
• Only ad-hoc practices with no documentation
• Quarterly social media audits
• Patent filing for each donation

Correct Answer: Current Good Manufacturing Practice (CGMP) and a documented quality management system

Q14. Which labeling element helps in identifying whether plasma is fresh frozen plasma (FFP) or frozen within 24 hours (PF24)?

• Storage location code only
• Product description indicating FFP or FP24 and date/time of freezing
• Donor’s blood pressure at donation
• Clinical diagnosis of recipient

Correct Answer: Product description indicating FFP or FP24 and date/time of freezing

Q15. Which pathogen reduction method is commonly applied to platelets and plasma to reduce transfusion-transmitted infections?

• Autoclaving at 121°C
• Solvent/detergent treatment for plasma and photochemical methods (e.g., amotosalen/UVA) for platelets
• Centrifugation only
• Boiling for 10 minutes

Correct Answer: Solvent/detergent treatment for plasma and photochemical methods (e.g., amotosalen/UVA) for platelets

Q16. Which organization in India provides national policy and guidelines specifically for blood transfusion services and hemovigilance?

• National Blood Transfusion Council (NBTC)
• Indian Council of Medical Research (ICMR)
• Reserve Bank of India (RBI)
• Bureau of Indian Standards (BIS)

Correct Answer: National Blood Transfusion Council (NBTC)

Q17. Which of the following is a typical maximum shelf-life and storage condition for platelets under standard regulatory guidance (without pathogen-reduction extension)?

• Stored at 1–6°C for 42 days
• Stored at 20–24°C with continuous agitation for up to 5 days
• Frozen at –80°C for 10 years
• Kept at room temperature without agitation indefinitely

Correct Answer: Stored at 20–24°C with continuous agitation for up to 5 days

Q18. Which practice is commonly required for labeling a blood product to indicate that further testing or processing (e.g., irradiation) has been applied?

• No indication is ever given on labels
• Clear label annotation stating the processing (e.g., “Irradiated”, “Pathogen reduced”) and date/time of processing
• Only internal paperwork records without label change
• Labeling with a generic “processed” barcode only readable by manufacturer

Correct Answer: Clear label annotation stating the processing (e.g., “Irradiated”, “Pathogen reduced”) and date/time of processing

Q19. Which requirement is central to the release of blood-derived medicinal products in the EU when they are regulated as medicinal products?

• Release by a Qualified Person (QP) after batch review and compliance verification
• Release based on oral approval only
• Release requiring no documentation
• Release only after two years in storage

Correct Answer: Release by a Qualified Person (QP) after batch review and compliance verification

Q20. Which of the following best describes a key labelling precaution required for all blood units to reduce risk of ABO-incompatible transfusion?

• Label must display only the donor’s name
• Label must display the ABO and Rh(D) blood group and unique donation identification
• Label must omit blood group to maintain donor anonymity
• Label must only show expiration date and no group information

Correct Answer: Label must display the ABO and Rh(D) blood group and unique donation identification

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