Introduction: This blog presents a focused set of multiple-choice questions on the Concept of cGMP and Schedule M guidelines tailored for M.Pharm students. The questions emphasize practical understanding of current Good Manufacturing Practices (cGMP), responsibilities of quality units, documentation, premises and utilities, validation, sampling, environmental monitoring, and the key provisions of Schedule M relevant to pharmaceutical manufacturing in India. Each question tests deeper comprehension required for quality assurance and regulatory compliance, rather than surface memorization. Use these MCQs to evaluate readiness for examinations and real-world QA/QC roles, and to reinforce critical thinking about GMP application in routine pharmaceutical operations.
Q1. What does the abbreviation cGMP stand for in pharmaceutical manufacturing?
- Current Good Manufacturing Practices
- Certified Good Manufacturing Procedures
- Compliance with Good Medicine Policies
- Controlled Generic Manufacturing Processes
Correct Answer: Current Good Manufacturing Practices
Q2. What is the primary objective of implementing cGMP in a pharmaceutical facility?
- To ensure consistent product quality, safety and efficacy
- To maximize production output regardless of quality
- To reduce staff numbers through automation
- To simplify packaging aesthetics only
Correct Answer: To ensure consistent product quality, safety and efficacy
Q3. Under Schedule M, which unit is principally responsible for approving or rejecting products for release?
- Quality Unit (Quality Assurance and Quality Control)
- Production Supervisors only
- Purchase Department
- Marketing Department
Correct Answer: Quality Unit (Quality Assurance and Quality Control)
Q4. Which of the following best describes the scope of Schedule M in the Drugs & Cosmetics rules?
- Regulatory requirements for premises, plant, equipment and good manufacturing practices in India
- Marketing guidelines for drug promotion only
- International tariffs for pharmaceutical exports
- Prescription writing standards for clinicians
Correct Answer: Regulatory requirements for premises, plant, equipment and good manufacturing practices in India
Q5. Which document serves as the detailed, step-by-step record for manufacturing a specific batch?
- Batch Manufacturing Record (BMR) / Batch Packaging Record (BPR)
- Quality Policy Statement
- Purchase Order
- Training Matrix
Correct Answer: Batch Manufacturing Record (BMR) / Batch Packaging Record (BPR)
Q6. Which activity is a core element of equipment qualification under cGMP?
- IQ/OQ/PQ sequence (Installation, Operational and Performance Qualification)
- Only visual inspection without testing
- Annual repainting of equipment surfaces
- Marketing validation of equipment brand
Correct Answer: IQ/OQ/PQ sequence (Installation, Operational and Performance Qualification)
Q7. Schedule M requires appropriate water quality for various operations. Which water type is typically required for parenteral production?
- Water for Injection (WFI)
- Potable tap water
- Distilled water for general cleaning only
- Deionized water without microbial control
Correct Answer: Water for Injection (WFI)
Q8. What is the main purpose of an effective HVAC system in pharmaceutical production areas?
- Control airborne contamination, temperature and humidity to protect product quality
- To provide decorative lighting effects
- To circulate outside air without filtration
- To maximize energy consumption
Correct Answer: Control airborne contamination, temperature and humidity to protect product quality
Q9. Which practice is essential to prevent cross-contamination between different product lines?
- Dedicated or well-controlled segregation of areas, equipment and personnel
- Using the same equipment for all products without cleaning
- Ignoring label segregation for speed
- Allowing material mixing in a common storage area
Correct Answer: Dedicated or well-controlled segregation of areas, equipment and personnel
Q10. What is the role of Standard Operating Procedures (SOPs) in a GMP environment?
- Provide written, approved instructions to ensure consistent performance of tasks
- Act as marketing brochures for clients
- Serve only as suggestions that staff can ignore
- Replace all training for personnel
Correct Answer: Provide written, approved instructions to ensure consistent performance of tasks
Q11. Which statement best describes the purpose of process validation?
- To demonstrate that a manufacturing process consistently produces product meeting predetermined specifications
- To speed up production without documentation
- To validate the marketing claims of a product
- To allow changes to process without assessment
Correct Answer: To demonstrate that a manufacturing process consistently produces product meeting predetermined specifications
Q12. What is the correct approach to handling out-of-specification (OOS) test results?
- Investigate the cause, document findings and take appropriate corrective actions
- Discard the results and retest until passing values appear
- Ignore the result if production is on schedule
- Release the batch immediately to avoid losses
Correct Answer: Investigate the cause, document findings and take appropriate corrective actions
Q13. Which activity is a required element of a robust change control system?
- Assessment of potential impact on product quality and regulatory status before implementation
- Immediate implementation without review
- Only documenting changes after they are made
- Allowing changes by any operator without approval
Correct Answer: Assessment of potential impact on product quality and regulatory status before implementation
Q14. In Schedule M, what is expected of the quality control (QC) laboratory?
- Be independent, adequately equipped and staffed to test raw materials, in-process samples and finished products
- Be merged with production to speed testing
- Perform only microbiological tests and no chemical analysis
- Outsource all critical tests without oversight
Correct Answer: Be independent, adequately equipped and staffed to test raw materials, in-process samples and finished products
Q15. What is the purpose of environmental monitoring in controlled production areas?
- Detect and trend microbial and particulate contamination to ensure controlled environment performance
- Monitor only the color of the walls
- Reduce documentation of cleaning activities
- Replace product testing entirely
Correct Answer: Detect and trend microbial and particulate contamination to ensure controlled environment performance
Q16. Which of the following best describes the correct sampling approach for raw materials?
- Representative, documented sampling using approved procedures and appropriate sample size
- Selecting the most convenient sample from the lot without documentation
- Sampling only from the first container received
- Taking a single visual inspection as sufficient sampling
Correct Answer: Representative, documented sampling using approved procedures and appropriate sample size
Q17. Why are retention samples (reserve samples) kept for finished products?
- To allow investigation of quality complaints, stability issues or disputes after release
- To be sold at discounted price later
- To provide free samples to visitors
- To use as raw material in production
Correct Answer: To allow investigation of quality complaints, stability issues or disputes after release
Q18. Which of the following is a critical outcome of an effective cleaning validation program?
- Demonstrated removal limits for residues and prevention of carryover between products
- Fewer cleaning cycles regardless of contamination
- Using stronger chemicals without assessment
- Cleaning only visible dirt and ignoring residues
Correct Answer: Demonstrated removal limits for residues and prevention of carryover between products
Q19. What should a product recall procedure include according to cGMP principles?
- Clear steps for identification, retrieval, notification, root-cause analysis and corrective actions
- Instructions to hide the issue from authorities
- Only verbal communication with no records
- Immediate disposal without investigation
Correct Answer: Clear steps for identification, retrieval, notification, root-cause analysis and corrective actions
Q20. What is the purpose of periodic self-inspection or internal audits in a GMP facility?
- To identify compliance gaps, drive continuous improvement and prepare for regulatory inspections
- To punish staff members publicly
- To replace the need for external regulatory inspections entirely
- To reduce the number of SOPs by deleting them
Correct Answer: To identify compliance gaps, drive continuous improvement and prepare for regulatory inspections
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
Mail- Sachin@pharmacyfreak.com