Pharmaceutical Quality Assurance Important Questions are most helpful for the B.Pharm 6th semester examination. You can also download the suggestions PDF.
Quality Assurance and Quality Management Concept
1. Name the important regulatory bodies that govern the pharmaceutical industry.
2. Discuss how the cGMPs were developed by the USFDA.
3. Explain the steps involved in developing a drug from initial discovery to the final marketing of the formulation.
4. Define the terms QA and QC and explain the differences between them.
5. Describe the functions of QA and QC in a pharmaceutical company.
6. What is cGMP? Highlight the important areas covered under cGMP guidelines.
Total Quality Management
1. Name the key thinkers of the quality movement and write about their concepts of quality.
2. Define TQM and discuss its advantages.
3. List the key elements of TQM and the tools it uses.
4. Explain how TQM principles are applied in the pharmaceutical industry.
5. Write a brief note about the concept of Quality by Design (QbD) in the pharmaceutical industry.
International Conference on Harmonization (ICH)
1. Define ICH and discuss how it came into being.
2. Explain the process of harmonization adopted for preparing new ICH guidelines.
3. Discuss the QSEM guidelines as per ICH.
4. Describe the ICH Quality guidelines.
5. Write a note on the ICH guidelines for stability testing of pharmaceutical products.
Pharmaceutical Quality by Design
1. Define the term ‘Quality by Design’. List its advantages and demerits.
2. Explain how the concept of QbD is related to the ICH guidelines.
3. List and explain a few important QbD tools used in the pharmaceutical industry.
4. Define the terms QTPP, CQA, CMA, and CPP in Quality by Design.
5. Write a note on FMEA and HACCP.
6. Discuss the concept of PAT and its advantages.
Introduction to ISO 9000 and ISO 14000
1. Define ISO and discuss its aims and principles.
2. Explain the history of ISO standards development.
3. What are the important elements of ISO 9000 certification?
4. Discuss the benefits of ISO certification for a pharmaceutical company.
5. Explain the ISO 9000 family of standards.
6. What is the significance of the ISO 14000 family of standards?
NABL Accreditation
1. Define the terms ‘Accreditation’ and ‘NABL’.
2. Write a note on NABL Accreditation and its advantages.
3. List the steps for NABL accreditation in India.
4. Describe how a laboratory must prepare for NABL accreditation.
Organization and Personnel
1. Explain the division of responsibilities between the Production and QC Heads in a pharmaceutical company.
2. Describe the types of training that must be given to personnel in a pharmaceutical unit.
3. What precautions must be taken from the health and hygiene point of view for personnel?
Premises – Design, Construction, Layout, and Maintenance
1. List the factors to be considered when deciding where to set up a pharmaceutical plant.
2. What are the important sanitation and utility requirements for pharmaceutical manufacturing areas?
3. Explain the different classifications of clean rooms as per the guidelines of the USFDA and Schedule M.
4. Define airlocks. Explain the different types and how they work.
5. Discuss the measures to be taken to maintain the environment of a pharmaceutical manufacturing plant.
Equipment and Raw Materials
1. List the important factors to be considered in equipment design and location.
2. Name and explain the three most important criteria that matter when purchasing equipment.
3. Describe the procedures followed for sampling and testing of raw materials.
4. Write a note on the labelling of raw materials.
5. Explain the steps in the approval/rejection of raw materials by the QC department.
Quality Control
1. Define QC and explain its role in the pharmaceutical industry.
2. Explain the organization and functions of the QC unit.
3. Describe the sampling and testing procedures followed by QC.
4. Define the term OOS result. How is the investigation of such results performed?
5. Classify packing materials used in the pharmaceutical industry.
6. Name and explain the different types of glass used for packaging pharmaceutical products.
7. Explain tests performed on glass containers for parenteral use.
8. Describe the tests to be performed on rubber closures.
9. Discuss the tests for plastic containers for ophthalmic preparations.
10. List and discuss the tests for paper and board used to make cartons.
Good Laboratory Practices for Non-Clinical Laboratories
1. Define GLP and discuss its scope.
2. Explain the personnel responsibilities in a non-clinical testing facility.
3. Discuss the important facilities to be provided in testing units where animal testing is performed.
4. Write a note on GLP requirements for documentation in a non-clinical testing laboratory.
5. Describe the grounds on which a testing facility may be disqualified.
6. Explain the steps of a testing facility’s disqualification by regulatory authorities.
Complaints, Recalls, and Waste Disposal
1. What is a product complaint? What are the different types of complaints?
2. Explain the handling of product complaints.
3. List the important information that must be present in a product complaint data sheet.
4. Describe voluntary and statutory recall of drug products.
5. Discuss the CDSCO classification of drug recalls.
6. Name any three major drug recalls in history and explain the reasons for these recalls.
7. Describe Schedule M requirements for waste disposal of pharmaceuticals.
8. Classify types of waste.
9. Explain any three methods of waste disposal of medicines.
10. List the steps in effluent treatment in a pharmaceutical facility.
Documentation in the Pharmaceutical Industry
1. Write a note on the significance of documentation in the pharmaceutical industry.
2. Explain important guidelines of Good Documentation Practices.
3. List measures to be taken for electronic documentation systems.
4. Define MFR, BMR, and SOP.
5. Describe the contents of an SOP.
6. Discuss the significance of logbooks and how they must be used for data recording.
7. Write a standard operating procedure for “Writing an SOP”.
8. What is a quality review and how is it different from a quality audit?
9. Name and describe the quality-related documents to be maintained in a pharmaceutical company.
Calibration and Validation
1. Define calibration and write a note on its significance.
2. How frequently must equipment be calibrated?
3. Discuss the different phases of the qualification of equipment.
4. What is a Validation Master Plan? What are its important elements?
5. Define analytical method validation.
6. Define the terms accuracy, precision, and specificity.
7. What are the detection limit and quantitation limit? Differentiate between them.
8. Explain linearity and range of a method.
Good Warehousing Practice and Materials Management
1. Discuss the requirements of good warehousing practices.
2. Explain the steps in receiving and storage of materials in the warehouse.
3. Enumerate the precautions to be taken when handling goods in the warehouse.
4. List and describe the records to be maintained in a pharmaceutical warehouse.
5. Explain the stock rotation principle used in pharmaceutical storage.
6. Discuss the segregation of materials in a warehouse.