Schedule M – details and significance MCQs With Answer

Schedule M – details and significance MCQs With Answer

by

Schedule M – details and significance MCQs With Answer

Schedule M of the Drugs and Cosmetics Rules lays down Good Manufacturing Practices (GMP) for pharmaceutical manufacturing in India. This topic covers premises design, sanitation, personnel, quality assurance (QA), quality control (QC) laboratories, documentation, validation, sterilization, water systems (WFI), HVAC, in-process controls, and batch record requirements. Understanding Schedule M is essential for B.Pharm students preparing for careers in regulatory affairs, production, quality assurance and compliance inspections. The significance includes ensuring product safety, efficacy, regulatory compliance and readiness for inspections under CDSCO/state authorities. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary purpose of Schedule M in the Drugs and Cosmetics Rules?

  • To define drug pricing regulations
  • To prescribe Good Manufacturing Practices for pharmaceutical establishments
  • To list approved drug formulations
  • To regulate advertising of medicines

Correct Answer: To prescribe Good Manufacturing Practices for pharmaceutical establishments

Q2. Which regulatory body is primarily associated with enforcing Schedule M standards at the national level in India?

  • Ministry of Finance
  • Central Drugs Standard Control Organization (CDSCO)
  • Food Safety and Standards Authority of India (FSSAI)
  • Ministry of Health and Family Welfare (only policy)

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q3. Which of the following is NOT a key area addressed by Schedule M?

  • Premises and building layout
  • Quality control laboratory requirements
  • Staff training and hygiene
  • Drug retail pricing mechanisms

Correct Answer: Drug retail pricing mechanisms

Q4. Schedule M requires the presence of which laboratory function within a pharmaceutical manufacturing unit?

  • Independent Quality Control (QC) laboratory
  • Marketing analysis department
  • Retail outlet quality checks
  • External contract research only

Correct Answer: Independent Quality Control (QC) laboratory

Q5. For sterile parenteral preparations, Schedule M specifically emphasizes control of which utility?

  • Compressed air quality and HVAC
  • Lighting intensity
  • Office air-conditioning
  • Packaging machine power supply

Correct Answer: Compressed air quality and HVAC

Q6. Which water grade is explicitly required for parenteral production under GMP principles emphasized by Schedule M?

  • Drinking water (tap)
  • Distilled water
  • Water for Injection (WFI)
  • Softened water

Correct Answer: Water for Injection (WFI)

Q7. What document records the exact manufacturing steps, ingredients and parameters for producing a specific batch as required under Schedule M?

  • Marketing authorization dossier
  • Master Batch Manufacturing Record (Master Formula)
  • Sales order form
  • Annual report

Correct Answer: Master Batch Manufacturing Record (Master Formula)

Q8. Which practice is a fundamental documentation requirement under Schedule M?

  • Verbal approvals for major changes
  • Good documentation practice with legible, dated, and signed records
  • Destruction of old batch records weekly
  • Anonymous entries for security

Correct Answer: Good documentation practice with legible, dated, and signed records

Q9. Schedule M requires validation of which processes to ensure consistent product quality?

  • Only marketing strategies
  • Critical manufacturing processes such as sterilization and aseptic operations
  • Employee payroll systems
  • Packaging artwork colors

Correct Answer: Critical manufacturing processes such as sterilization and aseptic operations

Q10. Which activity is part of in-process controls (IPC) mandated by Schedule M?

  • Checking raw material supplier annual turnover
  • Monitoring critical parameters (e.g., temperature, pH, fill weight) during production
  • Designing product labels
  • Calculating marketing margins

Correct Answer: Monitoring critical parameters (e.g., temperature, pH, fill weight) during production

Q11. Under Schedule M, which of the following best describes the required relationship between production and quality control?

  • QC reports to marketing
  • Production has full authority to release batches
  • QC must be independent and have authority to approve or reject batches
  • QC is optional for small batches

Correct Answer: QC must be independent and have authority to approve or reject batches

Q12. What is the significance of environmental monitoring as required by Schedule M?

  • To monitor external weather only
  • To assess particulate and microbiological contamination in manufacturing areas
  • To measure employee attendance
  • To check packaging aesthetics

Correct Answer: To assess particulate and microbiological contamination in manufacturing areas

Q13. Which personnel factor is emphasized by Schedule M for ensuring GMP compliance?

  • Adequate training, hygiene and defined responsibilities
  • Only hiring temporary staff
  • Allowing overlapping duties without records
  • Minimizing training to reduce costs

Correct Answer: Adequate training, hygiene and defined responsibilities

Q14. What type of records must be maintained for each batch according to Schedule M?

  • Batch Manufacturing Records with complete production and QC data
  • Only invoice and dispatch records
  • Only electronic marketing spreadsheets
  • Verbal summaries archived informally

Correct Answer: Batch Manufacturing Records with complete production and QC data

Q15. Schedule M’s requirements for premises layout primarily aim to:

  • Maximize retail area
  • Minimize cross-contamination and ensure logical material flow
  • Reduce the number of windows
  • Increase office space at the expense of production

Correct Answer: Minimize cross-contamination and ensure logical material flow

Q16. Which of the following is a GMP requirement for raw materials under Schedule M?

  • Accepting materials without identity checks
  • Quarantine until tested and released by QC
  • Immediate use on delivery without records
  • Storing all materials at room temperature regardless of stability

Correct Answer: Quarantine until tested and released by QC

Q17. Schedule M requires which system for handling complaints and adverse events?

  • No system is required
  • Formal documentation, investigation and corrective actions
  • Only telephone complaints logging
  • Transfer all complaints to marketing

Correct Answer: Formal documentation, investigation and corrective actions

Q18. Which statement about equipment cleaning and maintenance under Schedule M is correct?

  • Cleaning schedules are optional
  • Cleaning, sanitization and maintenance must be documented and verified
  • Equipment never needs calibration
  • Cleaning can be done without records if supervised

Correct Answer: Cleaning, sanitization and maintenance must be documented and verified

Q19. How should packaging materials be controlled according to Schedule M?

  • Stored together with finished products without checks
  • Controlled, inspected on receipt, and stored to prevent damage or contamination
  • Issued freely to production without traceability
  • Reused indefinitely without qualification

Correct Answer: Controlled, inspected on receipt, and stored to prevent damage or contamination

Q20. What is the role of the “responsible person” in Schedule M compliance?

  • Only handles packaging design
  • Ensures GMP implementation, approves batch release and maintains records
  • Manages catering services
  • Is not necessary if automated systems are used

Correct Answer: Ensures GMP implementation, approves batch release and maintains records

Q21. Schedule M expects manufacturers to have what kind of system for deviations and change control?

  • No documentation for deviations
  • Formal deviation reporting, investigation and approved corrective/preventive actions
  • Only verbal communication of changes
  • Change control only for marketing changes

Correct Answer: Formal deviation reporting, investigation and approved corrective/preventive actions

Q22. Which activity is essential before releasing a batch for sale under Schedule M?

  • Approval by the Quality Control/Quality Assurance function after review of all records and test results
  • Release based on production manager’s verbal assurance
  • Automatic release after packaging
  • Release only after one year of storage

Correct Answer: Approval by the Quality Control/Quality Assurance function after review of all records and test results

Q23. How does Schedule M address training records for personnel?

  • Training is not required
  • Training must be documented, updated and available for inspection
  • Only initial training needs documentation
  • Training certificates can be forged without consequence

Correct Answer: Training must be documented, updated and available for inspection

Q24. Which of the following best reflects Schedule M’s stance on waste disposal?

  • Waste can be dumped without controls
  • Controlled and documented disposal of waste to prevent contamination and environmental harm
  • Only hazardous waste requires documentation
  • Waste disposal is the responsibility of local municipalities only

Correct Answer: Controlled and documented disposal of waste to prevent contamination and environmental harm

Q25. Why is calibration of critical instruments required under Schedule M?

  • Calibration is unnecessary for QC
  • To ensure measurement accuracy and reliable quality control results
  • Only to satisfy auditors without impact on quality
  • Because instruments wear out faster when calibrated

Correct Answer: To ensure measurement accuracy and reliable quality control results

Q26. Which of the following is a correct requirement about storage of finished products under Schedule M?

  • Finished products should be stored under conditions that maintain their quality until expiry
  • Storage conditions are irrelevant after packaging
  • All products must be frozen regardless of stability
  • Finished products can be mixed in a single warehouse without segregation

Correct Answer: Finished products should be stored under conditions that maintain their quality until expiry

Q27. What is the expected frequency of internal audits as implied by GMP practice in Schedule M?

  • Never required
  • Periodic internal audits to verify GMP compliance and effectiveness of quality systems
  • Only external audits matter
  • Audits only when there is a complaint

Correct Answer: Periodic internal audits to verify GMP compliance and effectiveness of quality systems

Q28. According to Schedule M principles, the design of production premises should:

  • Encourage cross-flow of raw and processed materials
  • Separate incompatible operations and provide controlled traffic flow
  • Be designed purely for aesthetics
  • Maximize number of personnel in production at any time

Correct Answer: Separate incompatible operations and provide controlled traffic flow

Q29. Which of the following is a correct description of the role of QC stability programs in Schedule M context?

  • Unnecessary if product is released quickly
  • To monitor product quality over shelf life and support expiry dating
  • Only used for marketing claims
  • Stability data is kept confidential and not used for release decisions

Correct Answer: To monitor product quality over shelf life and support expiry dating

Q30. How does Schedule M compare with WHO GMP guidelines?

  • Schedule M contradicts WHO GMP in all aspects
  • Schedule M aligns with the principles of WHO GMP but includes specific Indian regulatory requirements and details
  • WHO GMP is less comprehensive and irrelevant to Schedule M
  • They are identical word-for-word

Correct Answer: Schedule M aligns with the principles of WHO GMP but includes specific Indian regulatory requirements and details

Leave a Comment