Introduction: Schedule T outlines the Good Manufacturing Practice (GMP) requirements for Indian Systems of Medicine, including Ayurveda, Siddha, and Unani. This guideline emphasizes quality assurance, documentation, sanitation, validated manufacturing processes, qualified personnel, raw material control, in-process checks, and finished product testing to ensure safety, efficacy, and consistency of traditional formulations. B.Pharm students must understand premises, equipment validation, laboratory standards, storage, packaging, labeling, and regulatory compliance under Schedule T to support quality control and risk management in herbal and ASU pharmaceutical production. Familiarity with Schedule T aids inspection readiness and quality audits. ‘Now let’s test your knowledge with 30 MCQs on this topic.’
Q1. What is the primary purpose of Schedule T in Indian Systems of Medicine?
- To provide marketing strategies for herbal products
- To define Good Manufacturing Practice (GMP) requirements
- To list traditional recipes for physicians
- To regulate retail pricing of Ayurvedic drugs
Correct Answer: To define Good Manufacturing Practice (GMP) requirements
Q2. Which systems of medicine are covered under Schedule T?
- Only modern allopathic medicines
- Ayurveda, Siddha, and Unani
- Homeopathy and Naturopathy only
- Cosmetics and nutraceuticals
Correct Answer: Ayurveda, Siddha, and Unani
Q3. Schedule T requires facilities for which of the following laboratory functions?
- Clinical trials coordination
- Quality control testing and analysis
- Advertising content creation
- Retail point-of-sale management
Correct Answer: Quality control testing and analysis
Q4. Under Schedule T, which document is essential to ensure traceability of raw materials?
- Marketing brochure
- Purchase orders only
- Raw material records and certificates of analysis
- Employee payroll records
Correct Answer: Raw material records and certificates of analysis
Q5. Which aspect of production does Schedule T emphasize to prevent cross-contamination?
- Open-air batching
- Segregation of processing areas and dedicated equipment
- Using same utensils for all products
- Mixing raw materials in retail stores
Correct Answer: Segregation of processing areas and dedicated equipment
Q6. What is required by Schedule T regarding personnel working in manufacturing?
- No training is necessary
- Personnel must be trained, medically fit, and identifiable
- Only contractual labor can be used
- Workers must design formulations
Correct Answer: Personnel must be trained, medically fit, and identifiable
Q7. Schedule T specifies requirements for which of the following documentation?
- Only advertising scripts
- Master formula records, batch records, and SOPs
- Personal diaries of managers
- Social media posts
Correct Answer: Master formula records, batch records, and SOPs
Q8. Which is a key requirement for premises under Schedule T?
- Proximity to market stalls
- Design to prevent contamination and allow cleaning
- Use of residential areas for processing
- Open ponds for raw material storage
Correct Answer: Design to prevent contamination and allow cleaning
Q9. For herbal preparations like Arishtas and Asavas, Schedule T emphasizes control of which process?
- Fermentation and controlled maturation
- Microwave drying only
- Packaging without testing
- Immediate sale after mixing
Correct Answer: Fermentation and controlled maturation
Q10. What does Schedule T require for medicinal plant raw materials?
- No documentation at receipt
- Identification, botanical verification, and testing for contaminants
- Mixing different species without records
- Only visual acceptance without testing
Correct Answer: Identification, botanical verification, and testing for contaminants
Q11. Which validation activity is explicitly encouraged by Schedule T?
- Validation of manufacturing processes and critical equipment
- Validation of marketing slogans
- Validation of staff vacation schedules
- Validation of building aesthetics
Correct Answer: Validation of manufacturing processes and critical equipment
Q12. Schedule T sets standards for which of the following in the quality control laboratory?
- Uncalibrated instruments only
- Properly equipped instruments, calibrated and validated methods
- Use of mobile phones for testing
- Outsourcing all tests without oversight
Correct Answer: Properly equipped instruments, calibrated and validated methods
Q13. Which practice is recommended by Schedule T to manage rejected or non-conforming materials?
- Reintroduce to production without review
- Quarantine, investigate, and decide disposition
- Sell at discount immediately
- Discard without recording
Correct Answer: Quarantine, investigate, and decide disposition
Q14. Under Schedule T, what is the importance of environmental monitoring?
- It is irrelevant for herbal products
- To ensure cleanliness, air quality, and prevent microbial contamination
- Only aesthetic monitoring is needed
- To measure noise levels for workers
Correct Answer: To ensure cleanliness, air quality, and prevent microbial contamination
Q15. How does Schedule T address stability testing for ASU products?
- No stability data required
- Requires stability studies to establish shelf life and storage conditions
- Stability testing only for synthetic drugs
- Store products indefinitely without testing
Correct Answer: Requires stability studies to establish shelf life and storage conditions
Q16. Which labeling requirement is emphasized by Schedule T?
- Minimal labeling with no ingredient information
- Clear labeling with batch number, manufacturing date, expiry, and storage conditions
- Use of decorative labels only
- Labels in an undecipherable script
Correct Answer: Clear labeling with batch number, manufacturing date, expiry, and storage conditions
Q17. What is Schedule T’s stance on cleaning and sanitation?
- Cleaning is optional
- Defined cleaning procedures and records for equipment and premises are mandatory
- Sanitation only for offices
- Cleaning once a year is sufficient
Correct Answer: Defined cleaning procedures and records for equipment and premises are mandatory
Q18. Which of the following is a requirement for equipment under Schedule T?
- Equipment must be decorative
- Equipment should be designed, maintained, calibrated, and validated as necessary
- Use of improvised tools without records
- Shared household utensils for production
Correct Answer: Equipment should be designed, maintained, calibrated, and validated as necessary
Q19. Schedule T requires which approach toward documentation of deviations?
- Ignore deviations unless noticed by customers
- Document deviations, investigate causes, and implement corrective actions
- Delete deviation records after completion
- Report deviations only annually
Correct Answer: Document deviations, investigate causes, and implement corrective actions
Q20. For packaging materials, Schedule T mandates:
- No control over packaging quality
- Use of suitable, clean, and validated packaging materials with records
- Using recycled materials without testing
- Packaging at retail shops
Correct Answer: Use of suitable, clean, and validated packaging materials with records
Q21. What is the role of a qualified person under Schedule T?
- To manage social media only
- To oversee GMP compliance, release batches, and ensure quality standards
- To design labels exclusively
- To sell products at fairs
Correct Answer: To oversee GMP compliance, release batches, and ensure quality standards
Q22. Which contamination tests are highlighted by Schedule T for herbal products?
- Only color testing
- Testing for heavy metals, pesticides, microbial contamination, and aflatoxins where relevant
- Only taste testing
- Only pH testing for all products
Correct Answer: Testing for heavy metals, pesticides, microbial contamination, and aflatoxins where relevant
Q23. How should complaints and adverse event reports be handled per Schedule T?
- Ignored if infrequent
- Documented, investigated, and corrective actions implemented; records maintained
- Forwarded to retailers only
- Printed in advertisements
Correct Answer: Documented, investigated, and corrective actions implemented; records maintained
Q24. What is the recommended practice for retention samples under Schedule T?
- No retention sample policy required
- Keep retention samples of each batch for defined period for future testing
- Destroy samples immediately
- Give samples away as promotional items
Correct Answer: Keep retention samples of each batch for defined period for future testing
Q25. Which record is essential for each manufactured batch according to Schedule T?
- Cooking recipes of cafeteria
- Batch manufacturing record with raw materials, steps, and quality checks
- List of employees’ favorite foods
- Only invoice to purchaser
Correct Answer: Batch manufacturing record with raw materials, steps, and quality checks
Q26. Schedule T requires which of the following for storage areas?
- Storage in open markets
- Controlled storage with proper shelving, pest control, and segregation of quarantined items
- Storage in basements without ventilation
- Mixing finished goods with raw wastes
Correct Answer: Controlled storage with proper shelving, pest control, and segregation of quarantined items
Q27. Which does Schedule T expect for in-process controls?
- No in-process testing
- Defined checks at critical stages to ensure process consistency and quality
- Random sampling without documentation
- Only final product inspection
Correct Answer: Defined checks at critical stages to ensure process consistency and quality
Q28. Regarding regulatory inspections, Schedule T compliance helps auditors to:
- Ignore manufacturing practices
- Assess adherence to GMP, documentation, and quality control protocols
- Focus only on sales figures
- Evaluate marketing budgets
Correct Answer: Assess adherence to GMP, documentation, and quality control protocols
Q29. For water used in manufacturing, Schedule T recommends:
- No quality requirements
- Use of potable or purified water with regular testing and documentation
- Use of untreated surface water
- Water from any source without records
Correct Answer: Use of potable or purified water with regular testing and documentation
Q30. Which overall benefit does adherence to Schedule T provide to ASU pharmaceutical products?
- Improves product quality, safety, regulatory acceptance, and consumer confidence
- Only increases production speed without quality focus
- Reduces documentation burden only
- Guarantees global market monopoly
Correct Answer: Improves product quality, safety, regulatory acceptance, and consumer confidence
