Legal requirements for formulation industry MCQs With Answer

Introduction:

This quiz collection on Legal requirements for formulation industry is designed specifically for M.Pharm students preparing for advanced coursework and regulatory examinations. It focuses on statutory frameworks, current Good Manufacturing Practices, documentation, validation, stability requirements, pharmacovigilance responsibilities, and other compliance aspects critical to formulation development and manufacturing. Each question encourages understanding of practical regulatory expectations—both national and international—so you can apply legal principles in real-world quality and manufacturing settings. Use these MCQs to test knowledge, identify gaps, and reinforce the regulatory thinking required for responsible roles in pharmaceutical formulation and production.

Q1. What does cGMP stand for?

• Central Good Manufacturing Policy
• current Good Manufacturing Practices (cGMP)
• compliance Good Manufacturing Procedures
• comprehensive Good Material Practices

Correct Answer: current Good Manufacturing Practices (cGMP)

Q2. Which Indian regulation specifically outlines GMP requirements for pharmaceutical manufacturing?

• Schedule Y of Drugs and Cosmetics Rules
• Schedule D of Drug Laws
• Schedule M of Drugs and Cosmetics Rules
• Schedule P of Pharmacy Regulations

Correct Answer: Schedule M of Drugs and Cosmetics Rules

Q3. Which document provides stepwise instructions and quantitative details to manufacture a specific batch?

• Certificate of Analysis
• Master batch manufacturing record (Master Formula Record)
• Stability protocol
• Change control form

Correct Answer: Master batch manufacturing record (Master Formula Record)

Q4. In the European regulatory framework who is primarily responsible for certifying and releasing a medicinal product batch for sale?

• Production Manager
• Quality Assurance Head
• Qualified Person (QP)
• Regulatory Affairs Officer

Correct Answer: Qualified Person (QP)

Q5. The ICH guideline Q1A(R2) deals primarily with which requirement?

• Validation of analytical methods
• Stability testing of new drug substances and products
• Packaging material specifications
• Good distribution practice

Correct Answer: Stability testing of new drug substances and products

Q6. What are the commonly used ICH accelerated stability conditions for many drug products?

• 25°C ±2°C / 60% RH ±5%
• 30°C ±2°C / 65% RH ±5%
• 40°C ±2°C / 75% RH ±5%
• 5°C ±3°C / refrigerated

Correct Answer: 40°C ±2°C / 75% RH ±5%

Q7. What is the primary objective of cleaning validation in a formulation facility?

• To ensure personnel wear correct PPE
• To demonstrate reproducible removal of product and cleaning agents to acceptable limits
• To verify packaging line speed
• To confirm label accuracy

Correct Answer: To demonstrate reproducible removal of product and cleaning agents to acceptable limits

Q8. Which international standard is commonly referenced for cleanroom air classification used in pharmaceutical manufacturing?

• ISO 9001
• ISO 14644-1
• ASTM E2500
• WHO TRS 996

Correct Answer: ISO 14644-1

Q9. Which document should record unexpected production events, investigation, and corrective actions?

• Master formula record
• Deviation report (with CAPA)
• Batch pack list
• Stability sample log

Correct Answer: Deviation report (with CAPA)

Q10. What is the main purpose of retaining reserve (retention) samples of finished products?

• To increase warehouse stock
• To allow investigation of customer complaints or stability failures
• To provide free samples for marketing
• To use as in-process controls

Correct Answer: To allow investigation of customer complaints or stability failures

Q11. Who bears primary legal responsibility for pharmacovigilance activities and reporting for a marketed medicine?

• Manufacturing operator
• Contract research organization (CRO)
• Marketing Authorization Holder (MAH)
• Hospital pharmacy

Correct Answer: Marketing Authorization Holder (MAH)

Q12. Which type of validation ensures that computerized systems used in manufacturing and quality comply with intended use and regulatory requirements?

• Analytical method validation
• Process validation
• Computerized systems validation (CSV)
• Packaging validation

Correct Answer: Computerized systems validation (CSV)

Q13. Serialization in pharmaceutical supply chains is primarily implemented to:

• Reduce production costs
• Increase batch sizes
• Prevent counterfeiting and enable traceability
• Extend product expiry

Correct Answer: Prevent counterfeiting and enable traceability

Q14. Which of the following is NOT a component of GMP?

• Documented procedures and records
• Qualified personnel and training
• Robust quality control and validation
• Marketing strategies to increase sales

Correct Answer: Marketing strategies to increase sales

Q15. What information does a Certificate of Analysis (CoA) typically provide?

• Marketing plan for the product
• Batch manufacturing schedule
• Test results of the batch against specified acceptance criteria
• Employee training records

Correct Answer: Test results of the batch against specified acceptance criteria

Q16. A Class I product recall generally indicates which of the following?

• The product is being recalled for labeling updates only
• The product may cause temporary discomfort but not serious harm
• The product may cause serious adverse health consequences or death
• The product is recalled due to business or packaging errors with no health impact

Correct Answer: The product may cause serious adverse health consequences or death

Q17. Who issues an official export certificate for pharmaceutical products in most countries?

• Local hospital director
• National Regulatory Authority (NRA)
• Retail pharmacy association
• Contract packaging vendor

Correct Answer: National Regulatory Authority (NRA)

Q18. What defines a stability-indicating analytical method?

• A method that is faster than routine testing
• A method that quantifies impurities without separating degradation products
• A method that separates and quantifies the drug and its degradation products accurately
• A method used only for raw material identification

Correct Answer: A method that separates and quantifies the drug and its degradation products accurately

Q19. What is the primary purpose of a formal change control system in pharmaceutical manufacturing?

• To permit uncontrolled experimental changes
• To assess and manage changes so product quality is not adversely affected
• To speed up regulatory filings by bypassing review
• To record marketing changes only

Correct Answer: To assess and manage changes so product quality is not adversely affected

Q20. Environmental monitoring in aseptic manufacturing areas typically includes which of the following?

• Airborne particle counts, viable air and surface monitoring, and fingertip/glove sampling
• Only temperature monitoring
• Only visual inspection of cleanliness
• Noise level and light intensity measurements

Correct Answer: Airborne particle counts, viable air and surface monitoring, and fingertip/glove sampling

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