Industrial Pharmacy II- Question Bank_copy.pdf

Industrial Pharmacy II (SEM VII) Question Bank Second Sessional Examination Unit II and Unit IV MCQ’s Variation within a batch belongs to which source of Quality variation a)...

Industrial Pharmacy II (SEM VII) Question Bank Second Sessional Examination Unit II and Unit IV MCQ’s Variation within a batch belongs to which source of Quality variation a) Methods b) Machines c) Materials d) Personnel The benefits of GLP is a) More time spent on re work b) Reduces overall productivity c) Decreases reliability d) Increases right first time result Technological transfer is brought about by a) Quality Assurance department to manufacturing unit b) Quality control department to manufacturing unit c) Research and development department to manufacturing unit d) Quality Assurance department to research and development department. _____________ is defined as the systematic approach to development that begins with predetermined objectives and is based on Quality risk management. a) ISO Certification b) Total Quality Management c) Quality by Design d) Six Sigma approach Which of the following is a category of change. a) Temporary b) Critical c) Permanent d) Neutral A group of technologies that are used as base upon which other technologies or processes are developed is a) PAT technology b) QBD technology c) Platform Technology  d) Platinum Technology Technology transfer guidelines issued by a) MHRA b) WHO c) FDA d) CSCO NRDC implies a) National Revenue Development Council b) National Research Development council c) National Research design council d) National Revenue Design Council Which of the following parameters relates to the “Sig sigma approach” a) Errors b) Cost c) Safety d) Defects Full form of BCIL a) Batch consortium India limited b) Biotech consortium India Limited c) Biologic consortium India limited d) Bioenzyme consortium India limited Change control is affected by all the following reasons EXCEPT a) Management b) Quality assurance c) GMP requirement d) Regulatory requirement Module 4 of NDA dossier as per CTD format includes a) Clinical study reports b) Quality overall summary c) Preclinical study reports d) Administrative information. Following is the major part of Toxicology study a) Determination of bioavailability of drug b) Determination of bioequivalence of drug c) Determination of therapeutic index of drug d) Determination of metabolism of drug. Following test is performed to indicate Geno toxicity a) Draize test b) Ames test c) LAL test d) Endotoxin test ICH Q9 guidelines describe about a) Technology transfer b) Risk management c) Stability study d) Analytical method validation Bloom strength determines the strength of a) Tablet b) Capsule c) Pellets d) Granules Module 5 of NDA dossier per CTD format includes a) Clinical Study reports b) Quality overall summary c) Preclinical study reports d) Administrative information. Horizontal technology transfer takes place between a) Quality Assurance department to manufacturing unit b) One manufacturing unit to another manufacturing unit c) Research and development department to manufacturing unit d) Quality Assurance department to research and development department. Following ICH guideline mention about product development a) Q4 b) Q8 c) Q9 d) Q10 In CTD which of the following Modules is region specific a) Module 1 b) Module 2 c) Module 3 d) Module 4 Long Questions: (10 marks each) 1. Describe in details the goals and phases of technological transfer. 2. Describe the various specification of starting input materials in technology transfer. 3. What is six sigma, give its key features and discuss various methodology of six sigma. 4. Discuss in detail the Common Technical Document. Short Questions: (5 marks each) 1. Enlist different technology transfer agencies in India and describe objectives and functions of any one agency. 2. Elaborate on the elements of QbD as a part of QMS. 3. Define OOS and explain methods to handle or investigate an OOS. 4. Define receiving unit/Sending unit and activities conducted by receiving unit/ sending unit in technology transfer. 5. Enlist the various Quality Management System and explain TQM in detail. 6. Write a note on benefits, scope and procedure of NABL accreditation.