| LONG ESSAYS | 2×10=20 Marks |
| What is QSEM and discuss in details Q-series guidelines | |
| Discuss in detail the design, construction, plant layout and requirement of environmental control in sterile manufacturing unit | |
| Discuss the objectives and scope of GLP in Pharmaceutical industry | |
| Discuss in detail the principles of TQM | |
| Explain the facility requirements for maintenance of sterile manufacturing area | |
| Discuss the importance of Good Laboratory Practices Explain briefly the protocol content of non-clinical laboratory study | |
| List and explain Q series guidelines of ICH | |
| Describe the requirements s of organization and personal responsibilities as per schedule M | |
| Explain in detail the quality control test for packaging materials. | |
| Explain ICH Q1 guidelines for stability testing of drug and drug product | |
| Discuss briefly cGMP guidelines for construction, maintenance and sanitation of pharmaceutical unit | |
| Explain the objectives and scope of GLP | |
| Discuss the important principles of Total Quality Management | |
| Describe the requirements for environmental control and layout of sterile manufacturing area | |
| Explain the objectives and scope of GLP | |
| Describe in-detail the features of ISO 9000 and ISO 14000. | |
| Discuss the regulatory requirements for design, construction and plant layout of pharmaceutical manufacturing facility | |
| Explain the quality control tests for containers used in pharmaceutical packaging | |
| Discuss in detail about the concepts of Quality Assurance and GMP | |
| Explain about the quality control tests for containers and rubber closures | |
| Describe the design, construction and plant layout of a production unit | |
| Explain scope and objectives of GLP. | |
| Write in detail about personnel responsibilities, training and hygiene in pharmaceutical industry. | |
| Write in detail about NABL accreditation, principles and procedures. | |
| Give a detail account on stability testing of dosage form as per the ICH guidelines | |
| Discuss in-detail the salient features of Schedule-M | |
| Explain the objectives and scope of GLP | |
| What is QSEM and discuss in details Q-series guidelines | |
| Discuss in detail the design, construction, plant layout and requirement of environmental control in sterile manufacturing |
| Discuss the important principles of Total Quality Management |
| SHORT ESSAYS | 7×5=35 Marks |
| Describe the procedure for NABL accreditation | |
| Explain the steps involved in ISO 9000 registration | |
| What is CTD and explain module -2 | |
| Write the significance of personnel hygiene in pharmaceutical industry | |
| Describe the equipment selection and purchase procedure | |
| Explain the protocol for conduct of non-clinical laboratory study | |
| Explain the quality control tests for containers and rubber closures | |
| Discuss the handling of return goods | |
| Explain the importance and scope of validation | |
| Explain the concept of QA and QC | |
| Enlist ICH Q-series guidelines and explain any one in detail | |
| Describe the criteria for equipment selection in pharmaceutical industry | |
| How is cross contamination is prevented in dispensing unit | |
| Write the reasons for disqualification of testing facilities | |
| Describe the procedure for handling of return goods | |
| Write a short note on quality audit and quality review | |
| Explain the procedure for qualification of pH meter | |
| Describe the principle of analytical method validation | |
| Explain the principles are of TQM | |
| Explain the scope and features of NABL accreditation | |
| Discuss the steps involved in the purchase specification. | |
| Write a note on maintenance of stores for raw materials | |
| Give reasons for disqualification of testing facilities in GLP | |
| Explain briefly the protocol for conducting Non-clinical lab studies | |
| What are complaints and how they are evaluated? | |
| How do you handle disposal of waste products in pharmaceutical unit. | |
| Write the procedurefor qualification of UV- Visible spectrophotometer | |
| Write the elements of ISO 9000 | |
| Write the procedure for NABL accreditation | |
| How is the cross contamination prevented in dispensing and production areas. | |
| How do you audit vendor for ensuring purchase specification |
| Explain the QC test for secondary packaging material | |
| Discuss the procedure for conducting non clinical laboratory studies. | |
| Discuss the SOP for disposal of waste in pharmaceutical unit. | |
| Elaborate on master formula record | |
| Write the procedurefor qualification of UV- Visible spectrophotometer | |
| Write a note on ISO 9000 and ISO 14000 | |
| Explain briefly about ICH stability testing | |
| Discuss the maintenance of raw material stores | |
| Describe the SOP for purchase specification | |
| Explain the procedure for qualification of UV visible spectrophotometer | |
| Write a note on material Management | |
| Discuss the QC tests for secondary packing materials | |
| Explain briefly CTD and its modules | |
| Explain the handling of market complaints | |
| Explain the elements of QbD | |
| Describe the methods to prevent product contamination in sterile manufacturing unit | |
| Write the minimum criteria for selection of pharmaceutical equipments | |
| Explain the procedure for NABL accreditation | |
| Discuss the SOP for Handling of return goods | |
| Explain the guidelines to be followed for waste disposal in pharmaceutical industry | |
| Write in brief the material management in industry | |
| Describe the protocol for conduct of non-clinical laboratory study | |
| Enlist the reasons for disqualification of testing facility | |
| Discuss the tools and elements of QbD program | |
| Explain the protocol for conduct of non- clinical laboratory study | |
| Write a note on NABL Accreditation | |
| Describe briefly regarding equipment selection and purchase specification | |
| Write briefly about Master Formula Record | |
| Describe the maintenance of sterile area facilities | |
| Write a note on Good ware house practices | |
| What is DMF and explain its contents | |
| Summarize the reasons for disqualification of testing facility | |
| Write in brief on processing of pharmaceutical complaints. | |
| Explain the elements of TQM | |
| What are the steps involved in validation? |
| Differentiate between GLP and GDP. | |
| Describe the quality control tests for containers. | |
| Write in brief about preparation of new SOP. | |
| Write brief note on QbD tools. | |
| Write the process for maintenance of stores for raw materials | |
| Write the importance of personal hygiene in pharmaceutical industry? | |
| What criteria do you consider in location, design and construction of a sterile product | |
| Describe the quality control tests for rubber closures | |
| Explain the elements of QbD | |
| Enlist Q-series of ICH guidelines | |
| Discuss the SOP for purchase specification | |
| Define validation? Mention types and explain each of them | |
| Discuss the importance of BFR and MFR | |
| Explain the protocol for conduct of non-clinical laboratory study | |
| Describe the method of waste disposal in production department | |
| Describe the sterile area facility maintenance requirements | |
| Explain the steps involved in ISO 9000 registration | |
| Write the significance of personnel hygiene in pharmaceutical industry | |
| Describe the equipment selection and purchase procedure | |
| Discuss the environmental control and layout of sterile manufacturing area | |
| Differentiate the quality assurance and quality control departments in pharmaceutical industry | |
| Explain the quality control tests for containers and rubber closures | |
| Discuss the handling of return of goods | |
| Explain the importance and scope of validation |
| SHORT ANSWERS | 10×2=20 Marks |
| What are the benefits of ISO 9000? | |
| What are the elements of QbD | |
| Enlist the objectives of ICH | |
| State the importance of personal records in manufacturing | |
| Differentiate between validation and calibration | |
| Explain secondary packing material | |
| Write the importance of SOP in manufacturing | |
| Enlist the significances of batch formula record | |
| What the general principles of validation | |
| Define accuracy and precision |
| Define QbD | |
| Enlist the benefits of ISO 14000 | |
| Name any four Deming’s principles of quality management | |
| What are the steps involved in the purchase of raw materials | |
| What are the personnel requirements as per GLP | |
| Explain the role of SOP in manufacturing unit | |
| What is Master formula record | |
| What is FIFO and LIFO | |
| Name any two parameters for qualification of UV-visible spectrophotometer | |
| Write the importance of calibration | |
| Write the difference between QA and QC | |
| What are the benefits of QbD | |
| Write a note on personal hygiene in pharmaceutical unit | |
| Name different types of containers used in pharmaceutical industries | |
| What is DMF and give its importance. | |
| What is quality audit and quality review | |
| Write the difference between qualification and validation | |
| Explain the concept of FIFO | |
| Write the difference between prospective and retrospective validation | |
| Write the objective of ISO14000 | |
| Write any four elements of TQM | |
| Define QA and QC | |
| What is cross contamination and mix up contamination | |
| Name any four types of closures | |
| What is DMF? Give its importance | |
| What is quality audit and quality review | |
| Define calibration ,qualification and validation | |
| Write briefly the scope of validation . | |
| Name the parameters used for analytical method validation. | |
| What is the difference between QMS and EMS. | |
| Define TQM | |
| What are the materials used for secondary packaging? | |
| Differentiate calibration and qualification | |
| Define MFR | |
| What are the objectives of validation | |
| Write about quality documentation | |
| What are the personal responsibilities in plant layout | |
| Enlist Q series of ICH guidelines | |
| Define NABL accreditation | |
| Name different types of validation | |
| What is Batch formula record? |
| Define Qualification and validation | |
| Differentiate between quality control and Quality assurance | |
| What are secondary packaging materials? Give examples | |
| Define TQM | |
| Differentiate QMS and EMS | |
| Define is BMR and BPR | |
| Write the importance of quality documentation | |
| Name any four parameters for validation of analytical method | |
| What is the significance of calibration | |
| What is the difference between Quality Assurance and Quality control | |
| Define standard operation procedure (SOP) | |
| What is BMR | |
| Define calibration and validation | |
| Mention the elements of ISO 9000 | |
| Define QbD | |
| What is contamination and cross contamination | |
| Define Validation Master Plan. | |
| What are secondary packing materials give example. | |
| Define accuracy and precision. | |
| What is batch formula record? | |
| Define calibration. | |
| Give the importance of Quality control. | |
| What is ISO 14000? | |
| Define ICH guidelines | |
| What is secondary packing materials? Give two examples. | |
| What is Quality review? | |
| What is ‘Recall’ in pharmaceutical industry? | |
| What are types of qualifications? | |
| Define Validation. | |
| What is quality assurance and TQM? | |
| Define quality assurance and quality control | |
| What is contamination and cross contamination | |
| Differentiate ISO 9000 and ISO 14000 | |
| What is CTD | |
| Define and classify containers | |
| Differentiate calibration and qualification | |
| Write the importance of SOP | |
| What is LIFO and FIFO | |
| Enlist the merits of warehousing | |
| What are the benefits of ISO 9000? | |
| What are the elements of QBD |
| Enlist the objectives of ICH | |
| State the importance of personal records in manufacturing | |
| Describe the design of sterile manufacturing | |
| Explain secondary packing material | |
| Write the importance of SOP in manufacturing | |
| Enlist the significances of batch formula record | |
| What the general principles of validation | |
| Explain the importance of validation |