Download PTU M-Pharma 2019 May 2nd Semester 74927 QUALITY CONTROL and QUALITY ASSURANCE Question Paper

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Total No. of Pages : 01

Total No. of Questions : 06

M.Pharmacy(Pharmaceutical Analysis) (2017 Batch) (Sem.-2)

QUALITY CONTROL & QUALITY ASSURANCE

Subject Code : MPA-203T

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Time: 3 Hrs.

M.Code: 74927

Max. Marks: 75

INSTRUCTIONS TO CANDIDATES :

1. Attempt any FIVE questions out of SIX questions.

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2. Each question carries FIFTEEN marks.

1. a) Define the term “Quality”? Comment on “Quality should be built into the product, and testing alone cannot be relied onto ensure product quality” (2,4)

   b) Explain the role of GMP and GLP in maintaining the quality into the product. (9)

2. a) What is the principal difference among the Master Formula Record, Master Production and Control Record, Manufacturing Formulae and Processing instructions and Master Manufacturing Instructions and Packaging Instructions? (8)

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   b) Describe the structure/contents of MFR and MPCR. (7)

3. a) Define Pharmaceutical Manufacturing Documents (PMD). Explain different steps in total PMD. (2,5)

   b) Explain the guidelines for designing and implementing PMD programme (8)

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4. What is the legal Status of cGMP? Explain cGMP guideline as per USFDA. (3, 12)

5. a) What is the role/importance of IPQC tests in quality in any finished pharmaceutical products? Explain various IPQC test for solid and parenteral products. (2,6)

   b) Comment on the “Sanitation of manufacturing premises” and Prevention of Mix-Ups and cross contamination” in pharmaceutical manufacturing operations and controls in view of cGMP. (7)

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6. Discuss any three of the following : (3×5)

   a) How to write Standard Operating Procedure

   b) ICH Q6A guidelines

   c) Goods ware housing Practice

   d) CPCSEA

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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.

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