Alliance Institute of Advanced Pharmaceutical and Health Sciences Industrial Pharmacy (IPCT-2.4) Unit-I 1. 2. 3. 4. 5. Define mixing.

Explain different mixing mechanisms involved in fluids. Explain briefly about batch mixing and continuous mixing process. Explain the equipment involved in solid mixing with suitable diagrams. Write in detail about the mixing mechanisms involved in the solid mixing. Define blending and mixing. Explain the working principle of convection mixers, diffusion mixers and pneumatic mixers. 6. What are the factors to be considered while selecting the equipment for fluid mixing and solid mixing?. 7. Define milling and explain significance of milling in pharmaceutical operations. 8. Explain the importance of particle size distribution in milling process. 9. Explain the methods for the measurement of particle size distribution. 10. What are the basic parts of the mill and explain about different types of mills with suitable diagrams. 11. Explain about the various factors that influence milling. 12. Write a note on theory of comminution. 13. Write a note on techniques involved in milling. 14. Explain about the mill that works on attrition and impact and impact mechanism. 15. Explain in detail about ball mill and colloidal mill with suitable diagrams. 16. Define drying and explain about significance of drying. 17. What is the critical factor in drying operations and explain it. 18. Explain about a) Theory of drying b) Drying of solids 22. Explain the terms a) Equilibrium moisture content b) Equilibrium relative humidity c) Water activity 23. Classify dryers and explain any one dryer under each category with suitable diagrams. 24. Explain in detail a) Tray dryer b) Freeze dryer c) Microwave dryer 25. Define filtration and write in detail about theory of filtration. 26. Define the terms a) Cake filtration b) Sterile filtration c) Surface filtration 27. Write a note on filter media and filter aids. 28. Explain the filter selection criteria for sterile and non-sterile operations. 29. Describe the common integrity tests used to predict the performance of the filter. 30. Explain in detail about a) Plate and frame filter press b) Edge filter c) Membrane ultra filtration. 31. Define sterilization and classify and explain the methods of sterilization. 32. Explain in detail about the thermal methods of sterilization. 33. Explain in detail about chemical and non-thermal methods of sterilization. 34. Discuss dry and wet granulation. Write in detail about the fluid bed granulation unit operation.

35. Explain in detail the effect of moisture on pharmaceutical solids. 36. Explain the process parameters in roller compaction. 37. Define slugging and explain the process parameters in slugging. 38. Why wet granulate and give some disadvantages of wet granulation. 39. Explain the factors in wet granulation and how to determine the granulation end point. 40. Explain the process parameters in fluid bed granulation. 41. Classify granulators and explain them. 42. Explain the basic components of a tablet press with suitable diagrams. 43. Explain the operating principles involved in the preparation of soft gelatin capsules. 44. Classify and explain the equipment involved in soft gelatin capsule. 45. Explain about the adjustments to be made on tablet press. 46. Explain about the variables involved in tablet compression process. 47. Define consolidation and explain it. Unit-II 48. Explain various materials of construction for pharmaceutical equipment with special emphasis on steel. 49. What are the ideal characteristics of the material used in pharmaceutical packaging? 50. Write in detail about the glass containers used for the pharmaceutical packaging. 51. Explain about the various plastic materials used for packaging of drug products. 52. Write in detail about the various drug-plastic considerations. 53. Write in detail about the various closures used in packaging. 54. Write a note on basic plastic materials used in closures. 55. Define closure liners and what are the various factors in selecting the liners. 56. What are different tamper resistant packaging and write in detail about a) Strip packaging b) Blister packaging c) Bubble pack. 57. Write in-detail about scale-up techniques involved in the production of sterile products. 58. Write about the transfer scale-up considerations to the scale-up of liquid parenterals. 59. Write about scale-up agitation approaches in liquid pharmaceuticals. 60. Write in detail about the scale-up techniques involved in the production of semisolids. 61. Write in detail about transport phenomena involved in the scale-up of semisolids and also give a note on its relationship with mixing. 62. Explain about the scale-up problems involved in the production of semisolids. 63. Explain about the scale-up and monitoring of wet granulation process. 64. Define pilot scale and explain briefly about the scale-up techniques involved in the production of tablets. 65. Explain about the scale-up considerations in fluid bed spray granulator. 66. Explain the scale-up techniques involved in the production of capsules.

67. Write a note on mixing issues with tumbling blenders. 68. Explain the flow properties to be considered in the scale-up of powders. 69. Write about the basic approaches to avoid segregation. 70. Explain about the scale-up process parameters in fluid bed granulation. 71. Explain about the scale-up issues in pan coating and fluidized bed coating process. 72. Explain the scale-up techniques involved in the scale-up of suspensions. 73. Explain the scale-up techniques in pan-coating and fluidized bed coating processes. 74. Explain the scale-up techniques in the coating of tablets.

Unit-III 75. How the inventories are classified. Explain about the inventory management systems and how inventory reporting and analysis is done. 76. Explain about the economic lot size or order quantity. 77. Explain about the elements of cost control. 78. Why there is a need for sales forecasting and Explain the techniques involved in the sales forecasting 79. Explain about the policies and guidelines involved in the following a)Lay out of buildings b) Equipment and maintenance c) Material management 80. Write in detail about the industrial relations. 81. Explain about the handling and transportation of materials. Unit-IV 82. What is a statistical process capability. why there is a need for process capability. what are the assumptions regarding the statistical process capability. Write about the broad applications of process capability. 83. What are the computational methods in process capability and how do we interpret process capability. 84. Classify different types of SPC charts and explain in detail about them including their applications. 85. Explain the approaches of QOD and QOC .How to apply them in product development cycle. 86. Write about the tests for diagnosing the Special cause of variation. Write about pilot scale-up applications. 87. Write in detail about the a) R-charts b) S-charts c) X-bar and R-Charts. 88. Explain about the adulteration and misbranding in the pharmaceuticals.

Unit-V 89. What is a process validation and explain about the stages of process validation. 90. Why to enforce process validation in pharmaceutical products and Explain the regulatory basis of process validation. 91. Why do validation and why to apply process capability in process validation. 92. Explain the approaches and requirements to the process validation of solid dosage forms. 93. Explain the guidelines to the process validation of solid dosage forms. 94. Write the objectives and approaches for sampling diagrams. Explain the sampling diagrams for process operations and equipment. 95. Define the following a) Prospective b) Retrospective c) Concurrent d) Revalidation e) Installation qualification f) Operational qualification g) Critical process parameter h) State of control i) Validation change control 96. Explain about different validation documents. 97. Explain the approaches of prospective process validation. 98. Explain about the stratified nested sampling. 99. Explain the basic principles in the validation of sterile products. 100. Explain the validation of APIs. 101. When is cleaning verification appropriate? Explain the validation of a cleaning process. 102. Explain the possible parameters for analytical method validation.