Regulations related to manufacturing of dosage forms MCQs With Answer

Introduction: Regulations related to manufacturing of dosage forms are essential guidelines that ensure drug quality, patient safety, and regulatory compliance for B.Pharm students. These regulations cover Good Manufacturing Practices (GMP), documentation, validation (process, cleaning, analytical), stability testing, quality control, SOPs, batch records, and regulatory inspections by agencies like CDSCO, FDA and WHO. Understanding regulatory frameworks, ICH guidelines (Q1–Q10), and national laws helps future pharmacists manage production, quality assurance, audits, and recalls. Mastery of these topics prepares you for industry roles and for maintaining pharmaceutical compliance. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary objective of Good Manufacturing Practices (GMP) in pharmaceutical production?

• To reduce production costs regardless of quality
• To ensure consistent quality and safety of pharmaceutical products
• To speed up regulatory approvals
• To maximize batch output

Correct Answer: To ensure consistent quality and safety of pharmaceutical products

Q2. Which authority is the central regulatory body for approval of drugs in India?

• FDA (Food and Drug Administration)
• EMA (European Medicines Agency)
• CDSCO (Central Drugs Standard Control Organization)
• WHO (World Health Organization)

Correct Answer: CDSCO (Central Drugs Standard Control Organization)

Q3. Which Indian regulation specifically addresses GMP requirements for pharmaceutical manufacturing?

• Schedule T
• Schedule M
• Schedule Y
• Schedule D

Correct Answer: Schedule M

Q4. Which ICH guideline focuses on Quality Risk Management?

• ICH Q2
• ICH Q8
• ICH Q9
• ICH Q10

Correct Answer: ICH Q9

Q5. Which type of validation ensures a manufacturing process consistently produces product meeting predetermined specifications?

• Cleaning validation
• Process validation
• Analytical method validation
• Sterility validation

Correct Answer: Process validation

Q6. The main purpose of stability studies in regulatory requirements is to determine:

• Optimal packaging color
• Shelf life and appropriate storage conditions
• Production cost per batch
• Marketing claims for dosage convenience

Correct Answer: Shelf life and appropriate storage conditions

Q7. Which document provides a step-by-step record of materials, procedures, and operations for a specific batch?

• Validation Protocol
• Standard Operating Procedure (SOP)
• Batch Manufacturing Record (BMR)
• Certificate of Analysis (CoA)

Correct Answer: Batch Manufacturing Record (BMR)

Q8. What is the main purpose of cleaning validation in multi-product facilities?

• To increase throughput
• To ensure cleaning reduces residues to acceptable levels to prevent cross-contamination
• To calibrate equipment
• To validate analytical methods

Correct Answer: To ensure cleaning reduces residues to acceptable levels to prevent cross-contamination

Q9. Before releasing a sterile injectable batch, which test is essential according to pharmacopoeial requirements?

• Disintegration test
• Sterility test
• Moisture sorption test
• Friability test

Correct Answer: Sterility test

Q10. What does CAPA stand for in pharmaceutical quality systems?

• Corrective and Preventive Action
• Control and Production Assurance
• Calibration and Performance Assessment
• Compliance and Process Audit

Correct Answer: Corrective and Preventive Action

Q11. What type of review is performed by regulatory authorities to assess facility compliance with GMP?

• Internal audit
• Regulatory inspection
• Peer review
• Market surveillance

Correct Answer: Regulatory inspection

Q12. Change control in pharmaceutical manufacturing is primarily intended to:

• Speed up product launches
• Formally evaluate and approve changes to processes, equipment, or documents
• Reduce documentation burden
• Increase batch size arbitrarily

Correct Answer: Formally evaluate and approve changes to processes, equipment, or documents

Q13. Pharmacovigilance is concerned with:

• Manufacturing process optimization
• Marketing strategy for new drugs
• Monitoring and reporting adverse drug reactions
• Packaging design

Correct Answer: Monitoring and reporting adverse drug reactions

Q14. Which guideline covers validation of analytical procedures used in drug testing?

• ICH Q1A
• ICH Q2
• ICH Q7
• ICH Q10

Correct Answer: ICH Q2

Q15. Which department is responsible for final approval and release of a finished pharmaceutical batch?

• Production
• Regulatory Affairs
• Quality Assurance (QA)
• Quality Control (QC)

Correct Answer: Quality Assurance (QA)

Q16. In aseptic processing, which environmental classification denotes the critical clean zone for sterile operations?

• Grade D
• Grade C
• Grade B
• Grade A

Correct Answer: Grade A

Q17. Good Laboratory Practice (GLP) primarily applies to which type of studies?

• Clinical trials in humans
• Non-clinical safety studies and laboratory testing
• Marketing research
• Shelf-life stability studies only

Correct Answer: Non-clinical safety studies and laboratory testing

Q18. Which ICH guideline defines the Pharmaceutical Quality System framework?

• ICH Q7
• ICH Q8
• ICH Q9
• ICH Q10

Correct Answer: ICH Q10

Q19. A stability-indicating assay should be able to:

• Only quantify the active ingredient irrespective of degradants
• Detect and quantify the active ingredient and its degradation products
• Only measure pH changes
• Only test for microbial contamination

Correct Answer: Detect and quantify the active ingredient and its degradation products

Q20. Why are batch records and manufacturing documents retained by a pharmaceutical company?

• To increase warehouse usage
• For traceability, investigation of deviations, and regulatory inspection
• Only for employee training
• To avoid product recalls

Correct Answer: For traceability, investigation of deviations, and regulatory inspection

Q21. What is the purpose of a Validation Master Plan (VMP)?

• To schedule employee shifts
• To provide a high-level document describing overall validation policy and strategy
• To list marketed products only
• To serve as a marketing plan

Correct Answer: To provide a high-level document describing overall validation policy and strategy

Q22. How should incoming raw materials be handled before use in production?

• Used immediately on arrival
• Stored without testing
• Quarantined until tested and released by QC
• Released by production manager only

Correct Answer: Quarantined until tested and released by QC

Q23. Which ICH guideline addresses stability testing of new drug substances and products?

• ICH Q1A
• ICH Q3C
• ICH Q2
• ICH Q7

Correct Answer: ICH Q1A

Q24. Which regulatory document is specific to manufacture of sterile medicinal products in the EU?

• Annex 1 of EU GMP
• Annex 11 of EU GMP
• ICH Q7 Annex
• Pharmacopoeial monograph

Correct Answer: Annex 1 of EU GMP

Q25. A batch recall is most commonly initiated due to:

• Excess inventory
• Quality defect posing risk to patient safety
• Marketing changes
• New packaging design

Correct Answer: Quality defect posing risk to patient safety

Q26. Bioequivalence studies for generic products are required to demonstrate:

• Identical inactive ingredients
• Comparable rate and extent of absorption to the reference product
• Same manufacturing site
• Longer shelf life than reference

Correct Answer: Comparable rate and extent of absorption to the reference product

Q27. Which sequence correctly describes equipment qualification steps?

• PQ, IQ, OQ
• IQ, PQ, OQ
• IQ, OQ, PQ
• OQ, IQ, PQ

Correct Answer: IQ, OQ, PQ

Q28. Good documentation practices require that entries in records should be:

• Erased and rewritten when mistakes occur
• Legible, dated, and signed with no unauthorized alterations
• Kept only electronically without backups
• Anonymous and unsigned

Correct Answer: Legible, dated, and signed with no unauthorized alterations

Q29. Environmental monitoring in aseptic areas typically includes monitoring for:

• Only temperature
• Only humidity
• Viable and non-viable particulates
• Only sound levels

Correct Answer: Viable and non-viable particulates

Q30. Mandatory label information on finished pharmaceutical products normally includes:

• Only brand logo and marketing slogan
• Name of drug, strength, batch number, manufacturing and expiry date, storage conditions, and manufacturer
• Only price and barcode
• Only physician’s name

Correct Answer: Name of drug, strength, batch number, manufacturing and expiry date, storage conditions, and manufacturer

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