Total No. of Questions: 3] SEAT No. : P5736 [6110]-510 [Total No. of Pages : 2 Fourth Year B. Pharmacy BP7021 : INDUSTRIAL PHARMACY - II (2019 Pattern) (Semester-VII) Time : 3 Hours} (Max. Marks : 75 Instructions to the candidates: 1) All questions are compulsory. 2) Neat, labeled diagrams must be drawn wherever necessary. 3) Figures to the right indicate full marks. Q1) Answer the following (Any Five) (5) a) What are the elements of QbD? b) List out the significance of NABL accreditation, c) Define validation? Explain benefits of validation. 4d) Enlist methods of risk management. ¢) Describe different levels of scale up changes as per SUPAC. f) Define clinical trial and explain Phase II. g) Whatarecritical quality attributes? Q2) Answer the following (Any two) (20) a) Explain the regulatory approval process for New Drug Application. b) Explain the concept of Quality and Total Quality Management ¢) Explain the elements of ISO 9000:2000. 4) Describe documentation required in technology transfer. PTO. Scanned by TapScannerQ3) Answer the following (Any Eight) [40] a) Write a note on Platform Technology. b) Explain the responsibilities of regulatory affairs professionals. ©) Explain the requirements for pilot plant scale up of Liquid Orals. d) Write note on Certificate of Pharmaceutical Product (COPP). ©) Discuss the objectives and scope of GLP in Pharmaceutical industry. 1) Describe the Organization of CDSCO with flow diagram. 8) Write a note on Drug Technical Advisory Board (DTAB) and its functions. h) Write a note on Clinical research protocol. i) Explain the applications of Biostatistics in Pharmaceutical Product Development. D Explain the concepts of Six Sigma for Quality Improvement. & aA [6110]-510 2 Scanned by TapScanner2148424. BF Gul 74%8 Ba < B.PHARMACY (2019. ‘Total No.of Questions: 3} SEAT Na. PA-2609 [otal Nexo Pages? [5940)-7002 Final Year B. Pharmacy INDUSTRIAL PHARMACY -I (2019 Pattern) (Semester - VII) (BP702T) Time: 3 Hours} ax. Marks :75 Insracton to the candidates: 1) All Questions ae computers. 2) Neat labeled diagrams must be drawn wherever necessary 3) Figures othe right indicate fll marks. 01) Objective Type Questions (Answers S out of 7}: [53-15] 4) Whatis platform echnology? 1) What are the gous of quality management system? ©) Enlist methods of risk management 4) Whats performance qualification? ©) Whatare the dimensions of quality? 1) Whats vertical technology transfer? 2) What are the benefits of SO 140007 @2) Long Answers (Answer 2 out of 4 [210-20] 8) Whatis technology transfer? Explain granularity of ech transfer, bb) Describe do a required in technology transfer ©) Explain the regulatory approval process for New Drug Application. 4) Explain the elements of I$0 9000 : 2000 Pro. (03) Short Answers (Answer 8 out of 10) [85-40] 8) Describe SUPACSS level I changes for change in batch size. » is techmology transfer? ©) Write a note om technology transfer 44) Describe impact of change in equipment as per SUPAC ©) What ste certification process in accordance with ISO 9001? 1 Explain the organization and functions of CDSCO. 18) What is GLP and discuss the same Scanned by TapScannerQ3) Short Answers (Answer 8 out of 10): [8x5=40] a) Describe SUPAC SS level | changes for change in batch size. b) What is technology transfer? ) Write a note on technology transfer agencies in India. d) Describe impact of change in equipment as per SUPAC. e) What is the certification process i ‘cordance with ISO 9001? f) Explain the organization and functions of CDSCO. g) What is GLP and discuss the same. h) Explain the concepts of six sigma for Quality Improvement i) What is clinical research protocols and data presentation? j) Write short note on various phases of clinical trials. Scanned by TapScanner‘Total No. of Questions : 3] SEAT No. : P888 [6019}-7012 {Total No. of Pages : 1 Fourth Year B. Pharmacy BP-702(T) : INDUSTRIAL PHARMACY - II (2019 Pattern) (Semester - VII) Time : 3 Hours} (Max. Marks :75 Instructions to the candidates: 1) Answer all questions. 2) Figures to the right indicates full marks. 3) Assume suitable data, if necessary. Q1) Objective Type Questions (Answer 5 out of 7) ISx3=15] a) Whatis platform technology. b) Whatis qualification? c) Explain role of various ICH guidelines useful in tech transfer. d) What are the elements of QbD? e) Define clinical trial and explain Phase II f) List out the significance of NABL accreditation. g) Describe i ‘about State licensing authority? 02) Lang Answers (Answer 2 out of 4). [2 x 10 = 20) Describe SUPAC guidance for all levels of changes in batch size. S Describe various technology readiness levels. ©) _ Explain the stages in the development of new drug. 4) Explain the concepts of Total Quality Management and Quality by Design (QbD). Q3) Short Answers (Answer 8 out of 10). [8 x 5= 40] a) _ Explain risk management in technology transfer. b) Describe which post approval specification changes don’t require permission? ©) Explain failure mode effect analysis. d) Explain process validation. €) Whatis confidentiality agreement? £) Whats platform technology? g) Explain the organization and functions of CDSCO. h) Explain the concepts of six sigma for Quality Improvement. i) — Write short note on various phases of clinical trials. ) Explain the terminology QTPP and CPP with suitable example. seo Scanned by TapScanner