Download PTU M-Pharma 2019 May 1st Semester 74700 QUALITY MANAGEMENT SYSTEMS Question Paper

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Total No. of Pages : 01

Total No. of Questions : 06

M.Pharmacy (Pharmaceutical Quality Assurance) (2017 & Onwards)

(Sem.-1)

QUALITY MANAGEMENT SYSTEMS

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Subject Code : MQA-102T

M.Code: 74700

Time: 3 Hrs.

Max. Marks: 75

INSTRUCTIONS TO CANDIDATES :

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1. Attempt any FIVE questions out of SIX questions.
2. Each question carries FIFTEEN marks.

Q1. Elaborate upon the following :

1. Quality (5)
2. Strategies of quality management (5)

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3. Factors affecting customer Perception (5)

Q2. a. Discuss the principle of six sigma. (8)

b. Write a note on ISO 9001: 2008. (7)

Q3. a. What do you understand by the concept of self inspection? (8)

b. What is the Vendor Qualification system? (7)

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Q4. a. ICH guidelines for accelerated stability studies. (9)

b. Write a note on quality by design. (6)

Q5. a. Define SPC. What is the importance of SPC in pharmaceutics? (10)

b. What are the advantageous of statistical control? (5)

Q6. Discuss in detail the advantages and disadvantages of Benchmarking. (15)

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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.