gjiv Gandhi Universi fajiv Gandhi University of Health Selene Karnataka + Pharm Degree Examination ~ ‘17-Mar-2028 Three Hours Max. Marks: 75 Marks ee en30. I runes iin ais E A the Questions plier F, a 2x10= 20 Marks ‘what are the different Ne ee ee and explain. pyscuss the granularity of TT, Discuss in dtall Tea A tore and excipients tort ESSAYS: 7x5 235 Marks wat are te objectives and significance of plot-plant? per WHO guidelines: pyscuss about documentation and premises for TT 25 How bioequivalence are documented? OR ‘ ties and write thelfresPo" nsibilitles: ame the various regulatory authori {grout the goals of TT { explain the different phases of out of specification analysis (005). « gxplain the significance of change control in quality management systems state licensing authority: 5 6. a g, Write a note on 9. ssponsibilities of cpsco? what are the res 10 x 2 = 20 Marks «for pilt-plant construction: ‘SHORT ANSWERS eral requirement 3g record? Wo, Name any four ge 11, What are the cifferent parts in batch manufacturin 12, What is drug master file? 43, Define technologY transfer accor CH What is Dossier? 15. what are the tye 16. pefine confidential ° 17. What is sx 19” 18. what are the ben its of Q00? 18, Name the aren modules of CT: .5 of IND? .greement @ scanned with OKEN Scannerpail Gandhi University of Health Sciences, Karnataka Vit Semester B, Pharm Degree Examination - 17-Nov-2022 | pre HOUTS \ Max. Marks: 75 Marks TDUSTREAL PHARMACY = IL Webb ge .P, CODE: 5030 answers should be specie the questions asked at labeled cagrams wherever necessary the Questions are compulsory YS beeen 2x10 = 20 Marks the various explain general requirements for setting up @ pilot plant for pharmaceutical preparation: piseuss the stages involved In technology transfer in pharmaceutical Industry: piscuss general consideration of investigational New drug application: 7x5 = 35 Marks yort ESSAYS 4 SHORT ANSWERS: 10. uw 12. B. 14 15. 16. v7 18. 19. piscuss the Importance of platform technology R How analytical methods are exchanged in a technology transfer explain technology transfer sample protocol in pharmaceuticals: R rite @ note on drug development team and their functions. piscuss the different phases of clinical trials. piscuss the objectives and scope of GLP in pharmaceutical Industry: escribe the procedure for NABL accreditation. piscuss the scope and objectives ‘of COPP (Certificate of pharmaceutical Product). write the functions of Drug Controller General of India (pce). 10x2= What is the difference between pilot scale and scale UP? What is SUPAC? What do you mean What is Operational What is 2 regulatory affair? What are its Goals? What are BA-BE studies? What is the need of BA-BE studies? Two advantages of implementing TOM: enlist the benefits of 15° 14000. “Two functions of Drugs technical advisory board (DTAB) hat is common technical document (CTD)? by Sending Unit and Receiving Unit ‘Qualification (00) and Performance Qualification (PQ) secre 20 Marks: al @ scanned with OKEN ScannerGandhi Uni Nivers} Vi Semesters, prsitY Of Health Sciences, K: ices, Karnataka arm D, | egree qpree Hours Examini e ation ~ 31-May-2023 L INDUSTRIAL PH Max. Marks: 75 Marks IARMACY ~ arks ‘Your enswers oy be CODE: S020. ae raw nest |; © specific to the she dagans ren | = jestions are compulsory pos [ exsein how master formula 2x 10 = 20 Marks ot le i records pect sie up studies, ae ‘and batch manufacturing records are developed in pilot peosss quality risk managemer : ‘ nt studi | eases the Role of regulatory seceronntocenn meen woe in pharma industry. bE suonT ESSAYS 7x5 = 35 Marks aris 2 pilot plant? What i i z, whet is 2 pilot plant? net ‘the significance of Pilot Plant scale up techniques? whet ere the Barriers of Technology Transfer? piscuss the TT Process of packaging materials. OR Exgizin the Different Phases of drug development. 5, Desorbe the key elements in managing clinical programs. 6. Wet are the advantages of implementing TQM? 7. What is the Benefits of NABL accreditation? trite 2 note on Central Drugs Testing Laboratories (CDTL)- Describe the Organization of CDSCO with flow diagram. SHORT ANSWERS 10 x2 = 20 Marks: 10, Enlist the significences of batch formula record. egorized as per SUPAC guideline LL. How equipment are 2 of Technology Transfer in Pharmaceutical Industry. 12. Write the two importance 12. Write the primary objectives NROC. 14. Write two key elements in managing clinical programs. 15. Wirite the significance Be study. 46. What is zero-defect PF ‘ of GLP? 47. What are the objectives oe ee sort offices of COSCO tions of Pt 5 eae types of rugs FOF hich COPPs may be issued. eit scene @ scanned with OKEN Scannery Gandhi Univers} ersit VII Semi ty of ‘ ester B. Pharm Y of Health Sciences, Karnataka Max, Marks: 75 Marks INI IDUSTRIAL PHARMACY - II ‘Your answers shee goo oEt 5030 Draw neat iebeladaepee oy questions asked | SW 7 Miho WUsetint Ge cheno ete arks jo essv5 ve Regulatory Requlreme a Rea nts for INDA approval process. 2x10 = 20 Marks L xpltn the concepts of Total Quality M . lanagem: explain the objectives and functions cbeca re ae Quality by Design (QbD)- SAYS: ig 7x5 = 35 Marks te a note on scale U scale up process approval changes ve the details about Quality Risk Management, 4. Discuss the Technology Transfer agencies in India. HORT 3, Wei plain the significance of documentation In BA = BE studies. 5, Write in detall about Pilot plant scale up considerations for soliés- f Write a note on documentation of finished products and packaging 3, What is clinical research protocols and data presentation? §, Write the elements of 15014000, piscuss the significance of GMP. materials. 3. 40 x2 = 20 Marks SHORT ANSWERS: 10. Write the significance of 1. Waite the guidelines for technology transfer (TT). ), write the functions of clinical studies. 13, What is State licensing authority? 14, What are the objectives of NRDC? 45, What are MoUs and confidential agreement? 16, Define qualification and validation. 17. Discuss the Role of Regulatory affairs department. 18, What is six sigma ‘concept and 00S? 0 9000. 19, Enlist salient features of 1S personnel requirements in pharm industry. epee @ scanned with OKEN ScannerRajiv Gandhi Universi tal 4 niversity of Health Sciences, Karnataka VII Semester B, are bagrse Examination ~ 24-Oct-2024 Time: Three Hours, Max. Marks: 75 Marks INDUSTRIAL PHARMACY = IL i Q.P. CODE: 5030 four answers should be specific tothe questions asked Draw neat labeled diagrams wherever necessary All the Questions are compulsory LONG ESSAYS 2.x 10 = 20 Marks 1, Explain the Heine for pilot plant scale up of Semisolids, Define technology transfer? Explain the different stages of technology 2. Explain the functioning of various Drug Development Teams. ‘SHORT ESSAYS 3 7x5 = 35 Marks Define clinical trials. Why are the clinical trials required? OR Write a note on Platform Technology, 4, _ Ust out Risk management methodology. oR Discuss the Equipment requirements for TT? t 5. Discuss the Scope and objectives of Regulatory Affairs. 6. Write a note on Investigator’s Brochure. Discuss the approval and implementation of Change control management System in Pharmaceutical Industry. 8, Write the Functions of Drugs Controller General of India (DCGI). 9. Describe the Process to apply for a COP, ‘SHORT ANSWERS 10 x 2 = 20 Marks 10, Name the contents of batch manufacturing record. 11. Name any four general requirements for pilot plant construction 12. WHO guidelines for technology transfer. 13. Write salient features of CTD. 14, Write the significances of BA-BE Study. 15. What is ADR reporting 16. Define TQM? What are the key elements of TQM? 17. Enlist the benefits of ISO 14000. 18, List out places of Zonal offices and Sub-zonal offices of CDSCO. 19. What is the scope of COPP? @ scanned with OKEN Scanner+, . . . ataka Rajiv Gandhi University of Health Sciences. Kam VIE Semester 8, pharm Degree Examination ~ 30-M2Y~ ‘ishes ye: Three Hours Max. Marks: 75 INDUSTRIAL PHARMACY ~ II Q.P. CODE: 5030 ‘Your answers should be specific to the questlons asked Draw neat labeled diagrams wherever necessary All the Questions are compulsory heessivt 2 10 = 20 Marks Explain the protocol ~ Pilot plant scale up for tablets production. Disa fe Gronulany of T Process for hei Phrmacestical Ingredients (A) end Expl the data’s to be submitted during New Drug Application (NDA) fing. sORT ESSAYS 7x5 = 35 Marks | discs the Significance of personne requirements in pit plant scale UP. Discuss the Documentation process involved in TT. 4. _piferentite Between qualification and validation with suitable examples at Discuss the Types of studies involved in Pre-ctinical Drug Development. =" ae 5, Describe the organization of CDSCO with proper flow diagram. ; need 6, Write anote on QbD concept as per ICH Q8 Guidelines. 1 Wiite a note ISO 14000 Guidelines. x CBRAT 8, Write a note on Drug Technical Advisory Board (DTAB) and its functions. 9, Discuss new drugs approval process in India, SHORT ANSWERS 40, What are the different parts of batch manufacturing record? ‘1, What Is platform technology? 12, Write any two reasons for technology transfer in Pharmaceutical Industry. 43, White the functions of BCIL, 14, Ust out various Regulatory Authorities. 15. Enlist the key elements in managing clinical programs. 16. 10 x 2 = 20 Marks ‘Write the four reasons for disqualification of testing facilities. 17, Classify Changes and give examples. 18. What is CTD? 19. Differentiate the assignable and non-assignable causes as per OOS. @ scanned with OKEN Scanner