UNIT - I: Quality Assurance and Quality Management Concepts (10 Hours)

2 Marks Questions (10 Questions)

1. Define Quality Control and explain its role in the pharmaceutical industry.
2. What is the difference between Quality Assurance and Quality Control?
3. State the basic elements of Total Quality Management (TQM).
4. Mention the key philosophies behind Total Quality Management (TQM).
5. What is the purpose of ICH guidelines?
6. List the participants involved in the ICH guidelines process.
7. What does QbD stand for and how does it benefit pharmaceutical production?
8. Name the key elements of the Quality by Design (QbD) program.
9. What are the benefits of ISO 9000 certification for an organization?
10. What are the steps for ISO 14000 registration?

5 Marks Questions (15 Questions)

1. Explain the concept of GMP (Good Manufacturing Practice) and its importance in
pharmaceutical manufacturing.
2. Discuss the main elements of Total Quality Management (TQM).
3. Describe the process of harmonization under the ICH guidelines.
4. Outline the key points in the ICH stability testing guidelines.
5. Define Quality by Design (QbD) and explain its significance in ensuring the quality of
pharmaceutical products.
6. Explain the tools used in the implementation of Quality by Design (QbD).
7. Discuss the principles behind ISO 9000 and ISO 14000 certifications.
8. Explain the process involved in obtaining NABL accreditation.
9. Describe the benefits of ISO 9000 certification and its impact on an organization.
10. Discuss the importance of having a proper Quality Assurance system in place in a
pharmaceutical organization.
11. Explain the role and significance of ICH guidelines in the global pharmaceutical industry.
12. Describe the Q-series guidelines in detail.
13. Discuss the importance of the ICH guidelines in maintaining consistency in drug
development.
14. How does ISO 9000 contribute to continuous improvement in an organization’s
processes?
15. What are the major steps involved in the QbD implementation for pharmaceutical
products?
UNIT - II: Organization and Personnel (10 Hours)

2 Marks Questions (10 Questions)

1. What are the key responsibilities of personnel in a pharmaceutical manufacturing

facility?
2. Why is training important in a pharmaceutical organization?
3. Explain the significance of hygiene and personal records in pharmaceutical
manufacturing.
4. What is the importance of plant layout in a pharmaceutical facility?
5. What are the basic requirements for premises in pharmaceutical manufacturing?
6. Define sanitation in the context of pharmaceutical manufacturing.
7. Why is environmental control important in pharmaceutical production?
8. What is meant by the control of contamination in pharmaceutical manufacturing?
9. How are sterile areas maintained in pharmaceutical facilities?
10. What are the considerations for the maintenance of utilities in pharmaceutical facilities?

5 Marks Questions (15 Questions)

1. Describe the personnel responsibilities in pharmaceutical production and their impact on

product quality.
2. Discuss the significance of training in a pharmaceutical organization and its relation to
GMP.
3. Explain the importance of maintaining hygiene and personal records in a pharmaceutical
company.
4. What are the key aspects of premises design and construction in pharmaceutical
manufacturing?
5. Discuss the role of plant layout in maintaining efficient pharmaceutical production.
6. Explain how sanitation and environmental control are critical in maintaining product
integrity.
7. Describe the maintenance procedures for utilities in pharmaceutical manufacturing.
8. Discuss the control measures for contamination in a pharmaceutical environment.
9. Explain the concept of maintenance of sterile areas in pharmaceutical facilities.
10. What factors should be considered when selecting equipment for pharmaceutical
manufacturing?
11. Explain the role of purchasing specifications in raw material selection for pharmaceutical
products.
12. Discuss the importance of maintaining raw material stores in a pharmaceutical
organization.
13. Describe the relationship between equipment maintenance and product quality.
14. Explain how the design and maintenance of premises contribute to GMP compliance.
15. Discuss the procedures involved in maintaining and ensuring the cleanliness of
pharmaceutical production areas.
UNIT - III: Quality Control and Good Laboratory Practices (10 Hours)

2 Marks Questions (10 Questions)

1. What are the general quality control tests performed for containers in pharmaceutical
manufacturing?
2. How are rubber closures tested for quality in pharmaceutical production?
3. What are secondary packing materials and why are they tested in pharmaceutical quality
control?
4. Define Good Laboratory Practices (GLP).
5. Mention the key provisions of Good Laboratory Practices.
6. What is the role of testing facilities in pharmaceutical GLP?
7. Describe the importance of protocol in the conduct of nonclinical laboratory studies.
8. What records and reports are essential in GLP?
9. What is the significance of disqualification of testing facilities under GLP guidelines?
10. Discuss the role of test and control articles in GLP studies.

5 Marks Questions (15 Questions)

1. Explain the various quality control tests required for pharmaceutical containers.
2. Describe the process and importance of testing rubber closures in pharmaceutical
manufacturing.
3. Discuss the quality control requirements for secondary packing materials in the
pharmaceutical industry.
4. Explain the key provisions and guidelines under Good Laboratory Practices (GLP).
5. Discuss the role of personnel and facilities in ensuring compliance with GLP.
6. What are the operational requirements for a pharmaceutical laboratory to comply with
GLP?
7. Describe the procedures and guidelines for maintaining testing facilities under GLP.
8. Explain the importance of a protocol in the conduct of nonclinical laboratory studies in
pharmaceutical companies.
9. Discuss the importance of maintaining proper records and reports in GLP-compliant
pharmaceutical labs.
10. What are the procedures involved in disqualifying testing facilities in case of GLP
violations?
11. Explain the role of test articles and control articles in GLP studies.
12. Discuss the importance of adhering to GLP guidelines in pharmaceutical testing.
13. Explain the significance of GLP in ensuring safety and efficacy of pharmaceutical
products.
14. Discuss the critical aspects of GLP in ensuring reproducibility and reliability of lab
results.
15. Describe the steps involved in conducting a nonclinical laboratory study under GLP.
UNIT - IV: Complaints, Document Maintenance, and Waste Disposal (8 Hours)

2 Marks Questions (10 Questions)

1. What are the steps involved in evaluating a complaint in the pharmaceutical industry?
2. How are return goods handled in the pharmaceutical industry?
3. What are the necessary steps for the recall of pharmaceutical products?
4. Explain the role of waste disposal in maintaining GMP.
5. What is a Batch Formula Record?
6. What is the significance of a Master Formula Record?
7. Explain the importance of Standard Operating Procedures (SOP) in pharmaceutical
operations.
8. What is a Quality Audit, and why is it conducted?
9. Define Quality Review in the pharmaceutical industry.
10. What is the role of documentation and distribution records in a pharmaceutical company?

5 Marks Questions (15 Questions)

1. Describe the procedures involved in handling and evaluating complaints in

pharmaceutical companies.
2. Discuss the importance of proper handling and disposal of return goods in maintaining
product quality.
3. Explain the process of recalling pharmaceutical products and the necessary actions to be
taken.
4. Describe the importance of waste disposal systems in pharmaceutical manufacturing.
5. What are the components and significance of a Batch Formula Record?
6. Discuss the role of a Master Formula Record in pharmaceutical manufacturing.
7. Explain the importance of SOPs in ensuring the consistent production of quality products.
8. What is the role and significance of conducting regular Quality Audits in a
pharmaceutical company?
9. Describe the steps involved in a Quality Review process.
10. Explain the significance of maintaining proper documentation and distribution records in
a pharmaceutical organization.
11. Discuss the legal requirements for documentation in pharmaceutical industries.
12. Describe the best practices for maintaining records related to production and distribution
in a pharmaceutical company.
13. Discuss the different methods for ensuring compliance with GMP during product recalls.
14. What is the role of documentation in traceability during quality control?
15. Explain the importance of proper training in handling complaints and waste disposal in a
pharmaceutical facility.
UNIT - V: Calibration, Validation, and Warehousing (7 Hours)

2 Marks Questions (10 Questions)

1. What is the definition of calibration in pharmaceutical manufacturing?

2. What are the general principles of qualification in pharmaceutical processes?
3. Define validation in the context of pharmaceutical industry.
4. What is the importance of the pH meter calibration in pharmaceutical manufacturing?
5. Describe the general principles of UV-Visible spectrophotometer qualification.
6. What is Analytical Method Validation?
7. What is the scope of validation in pharmaceutical manufacturing?
8. What are the types of validation processes in the pharmaceutical industry?
9. What is a validation master plan?
10. Explain the concept of Good Warehousing Practices (GWP).

5 Marks Questions (15 Questions)

1. Explain the definition and general principles of calibration in the pharmaceutical

industry.
2. Discuss the importance of qualification and validation in pharmaceutical processes.
3. Describe the calibration process for a pH meter and its significance.
4. Explain the process and principles of UV-Visible spectrophotometer qualification.
5. What are the general principles involved in Analytical Method Validation?
6. Discuss the types of validation conducted in pharmaceutical manufacturing.
7. Describe the scope of validation and its importance in the pharmaceutical industry.
8. What is the role of a Validation Master Plan in a pharmaceutical organization?
9. Explain the concept of Good Warehousing Practices (GWP) and its relevance to
pharmaceutical industry operations.
10. Discuss the importance of materials management and inventory control in pharmaceutical
warehousing.
11. Explain the role of environmental control in warehousing pharmaceutical products.
12. Describe the best practices for storing and handling pharmaceutical raw materials.
13. Discuss the significance of maintaining proper documentation in the warehousing
process.
14. Explain the principles behind materials management in pharmaceutical warehousing.
15. What factors should be considered while maintaining storage conditions for sensitive
pharmaceutical products?