Roll No.
Total No. of Questions : 06
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Total No. of Pages : 01
M.Pharmacy(Industrial Pharmacy) (2017 Batch) (Sem.-2)
SCALE UP & TECHNOLOGY TRANSFER
Subject Code : MIP-202T
M.Code: 74932
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Time: 3 Hrs.
Max. Marks: 75
INSTRUCTIONS TO CANDIDATES :
- Attempt any FIVE questions out of SIX questions.
- Each question carries FIFTEEN marks.
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Q1. a) Describe the scaling up process for tablets. Give its importance. (7.5)
b) How is the qualification of an autoclave done? (7.5)
Q2. Write notes on the following :
a) IQ for tablet compression machine (5)
b) Process validation parameter for sterilization (5)
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c) Aseptic room validation (5)
Q3. a) How can we scale up from pilot scale to large scale? Give suitable examples. (10)
b) Discuss the various safety measures to be taken in a pharmaceutical industry. (5)
Q4. a) Discuss in details the general concept, procedures and protocols involved in analytical validation process. (10)
b) Write a note on industrial effluent testing and treatment. (5)
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Q5. What do you understand by the term in process and finished product specifications? What are the various problems encountered during transfer of technology? (15)
Q6. Write short note on any three :
a) Performance qualification (5)
b) Qualification for a membrane filter (5)
c) Industrial effluent testing (5)
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d) Vendor qualification (5)
NOTE : Disclosure of Identity by writing Mobile No. or Making of passing request on any page of Answer Sheet will lead to UMC against the Student.
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