Schedule T of the Drugs and Cosmetics Rules defines Good Manufacturing Practices (GMP) for pharmaceutical products in India. It outlines mandatory requirements for premises, equipment, personnel, sanitation, documentation, quality control, validation, packaging, labeling, storage and stability testing to ensure product quality, safety and efficacy. B.Pharm students should grasp Schedule T to design compliant production systems, prepare SOPs, manage batch records, understand validation (IQ/OQ/PQ), environmental monitoring, sterile manufacturing and regulatory inspections. Key keywords: Schedule T, GMP, validation, master formula, batch record, stability studies, water quality, sterile processing and regulatory compliance. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which regulation contains Schedule T that prescribes GMP for pharmaceuticals in India?
- Indian Pharmacopoeia
- Drugs and Cosmetics Rules, 1945
- Food Safety and Standards Act
- Pharmacy Act
Correct Answer: Drugs and Cosmetics Rules, 1945
Q2. What is the primary objective of Schedule T?
- To increase production speed
- To ensure product safety, quality and efficacy through GMP
- To control drug pricing
- To register pharmacies
Correct Answer: To ensure product safety, quality and efficacy through GMP
Q3. Which of the following is NOT a typical requirement described in Schedule T?
- Premises and equipment standards
- Personnel training and hygiene
- Pharmacovigilance system for marketed drugs
- Documentation and batch records
Correct Answer: Pharmacovigilance system for marketed drugs
Q4. A master formula record should primarily contain which of the following?
- Marketing strategy and sales targets
- Composition, quantities, manufacturing steps and in-process controls
- Employee salary details
- Distributor contact lists
Correct Answer: Composition, quantities, manufacturing steps and in-process controls
Q5. The batch manufacturing record is used to:
- Forecast annual production volumes
- Record actual production, controls and deviations for each batch
- Determine marketing zones
- List competitors
Correct Answer: Record actual production, controls and deviations for each batch
Q6. Which activity is outside the scope of validation under Schedule T?
- Process validation (ensuring consistent product quality)
- Cleaning validation (ensuring removal of residues)
- IQ/OQ/PQ of equipment
- Market surveillance of competitor products
Correct Answer: Market surveillance of competitor products
Q7. What do the abbreviations IQ, OQ and PQ stand for in validation?
- Initial Quality, Ongoing Quality, Periodic Quality
- Installation Qualification, Operational Qualification, Performance Qualification
- Internal Quota, Outer Quota, Product Quota
- Inspection Quality, Operation Quality, Production Quality
Correct Answer: Installation Qualification, Operational Qualification, Performance Qualification
Q8. For parenteral and sterile products, which water quality is typically required?
- Treated potable water
- Water for Injection (WFI)
- Distilled water for cleaning only
- Municipal tap water
Correct Answer: Water for Injection (WFI)
Q9. Which control is essential for sterile product manufacturing under Schedule T?
- Controlled environment and aseptic processing
- Open bench mixing in production hall
- No personnel gowning required
- Only visual inspection of final product
Correct Answer: Controlled environment and aseptic processing
Q10. The purpose of stability testing required by Schedule T is to:
- Determine the cost of raw materials
- Establish shelf life and suitable storage conditions
- Identify marketing regions
- Train packaging staff
Correct Answer: Establish shelf life and suitable storage conditions
Q11. Retention samples are kept primarily to:
- Provide free samples to customers
- Permit future analysis in case of complaints or quality investigations
- Reduce storage costs
- Act as promotional material
Correct Answer: Permit future analysis in case of complaints or quality investigations
Q12. Which document is a direct example of required documentation under Schedule T?
- Standard Operating Procedure (SOP)
- Annual company brochure
- Employee personal emails
- Sales invoices to distributors
Correct Answer: Standard Operating Procedure (SOP)
Q13. The aim of regular self-inspection as per Schedule T is to:
- Replace regulatory inspections
- Identify deficiencies and initiate corrective actions
- Promote products to retailers
- Reduce employee training
Correct Answer: Identify deficiencies and initiate corrective actions
Q14. Which department holds primary responsibility for ensuring GMP compliance within a manufacturing unit?
- Sales and Marketing
- Quality Assurance (QA)
- Human Resources
- Finance
Correct Answer: Quality Assurance (QA)
Q15. Microbiological monitoring is mandatory in which areas?
- Warehousing only
- Clean rooms and sterile manufacturing areas
- HR office
- Outdoor loading docks
Correct Answer: Clean rooms and sterile manufacturing areas
Q16. The main difference between a master formula and a batch record is that a master formula:
- Is created after batch production
- Provides the standardized instructions, while the batch record documents execution
- Contains marketing details
- Is only used for sterile products
Correct Answer: Provides the standardized instructions, while the batch record documents execution
Q17. Which of the following is a critical aspect of packaging control under Schedule T?
- Label design aesthetics only
- Control of packaging materials and correct labeling
- Having the cheapest packaging available
- Outsourcing without any specifications
Correct Answer: Control of packaging materials and correct labeling
Q18. Personnel qualification and training under Schedule T should include:
- Only initial hiring qualifications with no ongoing training
- Initial qualification plus regular training and competency assessment
- Training only for managers
- Only on-the-job experience with no documentation
Correct Answer: Initial qualification plus regular training and competency assessment
Q19. The HVAC system in a pharmaceutical facility is important because it:
- Cools the canteen only
- Helps control temperature, humidity and particulate/microbial contamination
- Replaces the need for cleaning
- Is only used for comfort of office staff
Correct Answer: Helps control temperature, humidity and particulate/microbial contamination
Q20. In-process controls are performed to:
- Check final marketing labels
- Monitor critical parameters during production to ensure consistent quality
- Calculate employee bonuses
- Determine building maintenance schedules
Correct Answer: Monitor critical parameters during production to ensure consistent quality
Q21. Change control in a GMP environment is intended to:
- Allow unregulated quick changes
- Manage and document changes to processes/equipment to prevent adverse effects on quality
- Record employee shift changes
- Update marketing campaigns
Correct Answer: Manage and document changes to processes/equipment to prevent adverse effects on quality
Q22. Cleaning validation is performed to ensure:
- Equipment downtime is maximized
- Residual contaminants are removed to acceptable limits and cross-contamination is prevented
- Only visual cleanliness
- Packaging is glossy
Correct Answer: Residual contaminants are removed to acceptable limits and cross-contamination is prevented
Q23. The primary role of a Quality Control (QC) laboratory under Schedule T is to:
- Design packaging artwork
- Test raw materials, in-process samples and finished products for compliance
- Perform only microbial counts
- Conduct market research
Correct Answer: Test raw materials, in-process samples and finished products for compliance
Q24. Standard Operating Procedures (SOPs) are important because they:
- Provide standardized, controlled methods and ensure consistency and traceability
- Are optional guidelines for large companies only
- Are only for auditors to read
- Replace training entirely
Correct Answer: Provide standardized, controlled methods and ensure consistency and traceability
Q25. During regulatory inspections, Schedule T compliance is typically assessed by which authority in India?
- Food Safety and Standards Authority of India (FSSAI)
- Central Drugs Standard Control Organization (CDSCO) and state drug inspectors
- Reserve Bank of India
- Ministry of Finance
Correct Answer: Central Drugs Standard Control Organization (CDSCO) and state drug inspectors
Q26. Which statement about sterile filtration is correct?
- Sterile filtration is not acceptable for any parenteral solutions
- 0.22 µm filters are commonly used for sterilizing aqueous solutions and filtration must be validated
- Any filter pore size can be used without validation
- Sterile filtration eliminates the need for aseptic processing in all cases
Correct Answer: 0.22 µm filters are commonly used for sterilizing aqueous solutions and filtration must be validated
Q27. Environmental monitoring in a pharmaceutical plant typically includes monitoring of:
- Only final product weight
- Air, surfaces and personnel for particles and microbiological contamination
- Only the parking area
- Only finished product appearance
Correct Answer: Air, surfaces and personnel for particles and microbiological contamination
Q28. Distribution records and traceability are maintained to facilitate:
- Faster sales invoicing
- Efficient product recall and traceability in case of quality issues
- Only warehouse space planning
- Employee transportation schedules
Correct Answer: Efficient product recall and traceability in case of quality issues
Q29. The validation lifecycle generally includes which of the following stages?
- Design, installation, operation, performance qualification and ongoing monitoring
- Only marketing and distribution
- Hiring, firing and payroll
- Sales planning and target setting
Correct Answer: Design, installation, operation, performance qualification and ongoing monitoring
Q30. Why is understanding Schedule T important for B.Pharm students entering the pharmaceutical industry?
- It helps design promotional events only
- It enables understanding and implementation of GMP, quality systems, validation and regulatory compliance
- It replaces the need for pharmaceutical knowledge
- It is only relevant for medical doctors
Correct Answer: It enables understanding and implementation of GMP, quality systems, validation and regulatory compliance
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.
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