Schedule T—GMP for Indian systems: components and infrastructure MCQs With Answer

Introduction: This set of MCQs on Schedule T — Good Manufacturing Practices (GMP) for Indian Systems is designed for M.Pharm students specializing in Indian Systems of Medicine. It focuses on the components and infrastructure requirements mandated under Schedule T of the Drugs and Cosmetics Rules for Ayurveda, Siddha and Unani preparations. The questions cover premises and layout, equipment, quality control laboratory needs, documentation, personnel, raw material testing, packaging, stability, validation and recall systems. These MCQs will help reinforce regulatory understanding and practical implementation of GMP principles specific to traditional medicine manufacturing, aiding exam preparation and professional competence in regulatory compliance.

Q1. What is the primary purpose of Schedule T in the context of Indian Systems of Medicine?

• To provide marketing guidelines for traditional medicines
• To specify clinical trial procedures for herbal drugs
• To lay down Good Manufacturing Practices for Ayurveda, Siddha and Unani drugs
• To regulate pricing and distribution of traditional medicines

Correct Answer: To lay down Good Manufacturing Practices for Ayurveda, Siddha and Unani drugs

Q2. Which document is an essential GMP record required under Schedule T that gives a stepwise recipe and conditions for production of a formulation?

• Product marketing plan
• Master formula card
• Advertising brochure
• Employee attendance register

Correct Answer: Master formula card

Q3. According to Schedule T, how should the manufacturing premises be arranged?

• One large room for all activities to save cost
• Separate, defined areas for receipt, storage, processing and packing to avoid cross-contamination
• Open-air processing preferred for traditional authenticity
• Shared facilities with unrelated industries are acceptable

Correct Answer: Separate, defined areas for receipt, storage, processing and packing to avoid cross-contamination

Q4. What are the basic capabilities that a Quality Control laboratory should possess under Schedule T?

• Only organoleptic testing facilities
• Facilities for physical, chemical and microbiological testing with appropriate instrumentation
• Only microbiological testing for all products
• Marketing analysis and consumer survey capabilities

Correct Answer: Facilities for physical, chemical and microbiological testing with appropriate instrumentation

Q5. Which of the following statements about Standard Operating Procedures (SOPs) is correct under Schedule T?

• SOPs are optional and can be verbal
• SOPs must be documented, readily available and implemented for all critical operations
• SOPs are required only for managers
• SOPs should be rewritten monthly

Correct Answer: SOPs must be documented, readily available and implemented for all critical operations

Q6. What is the minimum water quality requirement for general manufacturing operations as per GMP principles in Schedule T?

• Any available tap water without testing
• Potable water for general use; purified water where quality requirements demand it
• Only distilled water for all operations
• Rainwater collection without treatment

Correct Answer: Potable water for general use; purified water where quality requirements demand it

Q7. Which tests are typically emphasized for raw herbal materials under Schedule T?

• Only visual inspection
• Identity, purity, strength, and contamination tests (e.g., heavy metals, pesticides, microbial limits)
• Only price verification and supplier credit checks
• Only moisture content measurement

Correct Answer: Identity, purity, strength, and contamination tests (e.g., heavy metals, pesticides, microbial limits)

Q8. What document contains the detailed record of manufacturing operations and in-process checks for each batch?

• Master formula card
• Batch manufacturing record (or batch processing record)
• Product pamphlet
• Vendor invoice

Correct Answer: Batch manufacturing record (or batch processing record)

Q9. Which of the following items must appear on the finished product label according to Schedule T principles?

• Manufacturer’s name, batch number, manufacturing and expiry dates, net quantity and storage instructions
• Only the product’s brand logo
• Detailed manufacturing SOPs
• Complete supplier addresses for all raw materials

Correct Answer: Manufacturer’s name, batch number, manufacturing and expiry dates, net quantity and storage instructions

Q10. Why are stability studies important under Schedule T for Indian systems formulations?

• They are only for marketing claims
• To establish and justify the shelf life and storage conditions of the finished product
• To reduce raw material costs
• To replace the need for quality control testing

Correct Answer: To establish and justify the shelf life and storage conditions of the finished product

Q11. What is the primary role of the Quality Assurance function as envisaged in Schedule T?

• To design marketing campaigns
• To ensure that manufacturing and quality operations comply with GMP and to approve batch release
• To handle only employee recruitment
• To perform only financial audits

Correct Answer: To ensure that manufacturing and quality operations comply with GMP and to approve batch release

Q12. Which practice is essential for equipment used in manufacturing under Schedule T?

• Equipment may be used without records
• Equipment must be designed for cleanability, routinely maintained, and calibrated with records kept
• Equipment should be replaced every week
• Only aesthetic appearance matters

Correct Answer: Equipment must be designed for cleanability, routinely maintained, and calibrated with records kept

Q13. What personnel requirements are emphasized under Schedule T for manufacturing of traditional medicines?

• No specific training; experience is enough
• Appropriate training in GMP, documented health checks and clear assignment of responsibilities
• Staff should be rotated daily between incompatible operations
• Only managerial staff require training

Correct Answer: Appropriate training in GMP, documented health checks and clear assignment of responsibilities

Q14. How should packaging and packing operations be managed according to Schedule T?

• Packing can be done in the same area as raw material receipt
• Packing areas should be clean, separate from production of incompatible items and designed to protect product quality
• Packing should be carried out outdoors for ventilation
• Packing staff can also handle raw material procurement simultaneously

Correct Answer: Packing areas should be clean, separate from production of incompatible items and designed to protect product quality

Q15. When sourcing herbal raw materials, which practice aligns with Schedule T expectations?

• Accepting raw materials solely based on low price
• Using approved suppliers, with documented specifications and identity testing on receipt
• Using only verbal supplier declarations without testing
• Purchasing all raw material from unverified local vendors

Correct Answer: Using approved suppliers, with documented specifications and identity testing on receipt

Q16. Which processes should be validated as per Schedule T principles?

• Only packing machine cleaning
• All critical processes where variability could affect product quality, such as extraction, concentration, sterilization or drying
• Only administrative procedures
• No process validation is required for traditional medicines

Correct Answer: All critical processes where variability could affect product quality, such as extraction, concentration, sterilization or drying

Q17. What must a manufacturer have in place to deal with a defective batch discovered after release?

• No formal measures; handle case-by-case
• A documented complaint handling and product recall procedure that can be promptly executed
• Only a public relations statement
• Immediate disposal of remaining stock without record

Correct Answer: A documented complaint handling and product recall procedure that can be promptly executed

Q18. How does Schedule T recommend storage conditions for bulk and finished products?

• Storage conditions are unimportant for herbal products
• Storage must be appropriate, controlled and monitored for factors like temperature, humidity and contamination
• Store all products in direct sunlight to preserve potency
• Stack products outdoors for natural drying

Correct Answer: Storage must be appropriate, controlled and monitored for factors like temperature, humidity and contamination

Q19. Schedule T is part of which regulatory framework governing traditional medicines in India?

• Food Safety and Standards Authority regulations
• Drugs and Cosmetics Rules (Schedule under the Drugs and Cosmetics Act)
• Forest conservation rules
• Checksum of international pharmacopeias only

Correct Answer: Drugs and Cosmetics Rules (Schedule under the Drugs and Cosmetics Act)

Q20. What is the purpose of environmental monitoring in manufacturing areas under Schedule T?

• To gauge employee comfort only
• To detect and control microbiological and particulate contamination that can affect product quality
• To monitor advertising effectiveness
• To replace finished product testing completely

Correct Answer: To detect and control microbiological and particulate contamination that can affect product quality

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