Dr.A.P.J.Abdul Kalam University B PHARMA VII SEM Industrial Pharmacy-II [BP702T] Dec - 2020 Question Paper

Dr.A.P.J.Abdul Kalam University

Bachelor of Pharmacy

Seventh Semester Main Examination, Dec-2020

Industrial Pharmacy-II [BP702T]

Time: 3:00 Hrs Max Marks 75

Note : (i) All parts of the question paper are compulsory.

(ii) All question of each part to be attempt at one place.

Part-A

Q.1 Multiple choice questions- [1x20 = 20 Marks]

(i) Which of the following is used for validation of hot air oven?

(a) Voltmeter (b) Pressure gauge

(b) Flowmeter (d) Stopwatch

(ii) Which of the following is an important aspect of Equipment validation?

(a) Instructional Qualification (b) Process Qualification

(c) Performance Qualification (d) Process Validation

(iii) Accuracy of an analytical method is expresses in terms of?

(a) % relative error (b) Mean

(c) % relative standard deviation (d) Median

(iv) The type of process validation which is based on information generated during

actual implementation of the process is known as _______________

(a) Prospective validation

(b) Retrospective validation

(c) Concurrent validation

(d) Analytical validation

(v) The guidelines that describe the Analytical Method Validation – Text &

Methodologyare?

(a) ICH Q2 (b) ICH Q1

(b) ICH Q8 (d) ICH Q9

(vi) The variable that is tested during validation of a powder blender is:

(a) Type of material (b) RPM

(c) Particle size of powder (d) Type of equipment

(vii) URS stands for?

(a) User Requirement Specification

(b) User Resource Specification

(c) User Retrospective Specification

(d) User Reference Specification

(viii) The variable for FBD control parameters includes:

(a) Air volume (b) Bowl change

(c) Bowl sieve (d) Porosity of filter bags

(ix) The amount of sample sampled for validation of a Tray Dryer is ______ g

(a) 4 (b) 1

(c) 3 (d) 2

(x) Pouching process is one of the unit operations of?

(a) Oral drug delivery

(b) Nasal drug delivery

(c) Transdermal drug delivery

(d) Ocular drug delivery

(xi) Which of the following in-process tests must be performed during compression stage

of tablet manufacturing?

(a) Drug solubility (b) Dissolution

(c) Hardness (d) Drug-excipient compatibility

(xii) APQR stands for?

(a) Annual Product Quality Reference

(b) Annual Process Quality review

(c) Annual Product Quality Review

(d) Annual Process Quality Reference

(xiii) MOC stands for?

(a) Material of Construction

(b) Material of Compression

(c) Material of Control

(d) Material of Cost

(xiv) Distance between two dies of a compression machine is checked with the help of?

(a) Optical micrometer (b) Screw gauge

(c) Vernier caliper (d) Monsanto tester

(xv) Performance Qualification checklist for compression machine includes:

(a) Punch shape (b) Disintegration time

(c) Drug solubility (d) Air velocity

(xvi) The lowest available capsule size is:

(a) 0 (b) 000

(c) 5 (d) 1

(xvii) Equipment Validation must be always done by?

(a) User (b) Vendor

(c) Manufacturer (d) Dealer

(xviii) Ribbon Thickness is one of the variables for validation of _________ filling machine

(a) Soft gelatin capsule (b) Hard gelatin capsule

(c) Pellet (d) Tablet

(xix) cGMP stands for?

(a) Compendium Good Monitoring Practices

(b) Compendium Good Manufacturing Practices

(c) Current Good Manufacturing Practices

(d) Current Good Monitoring Practices

(xx) Regulatory basis of process validation is available in:

(a) FDA (b) USP

(c) IP (d) BP

Part-B

Long answer questions. [10x2 = 20 Marks]

Note : Attempt any two questions. Each question carries 10 marks.

Q.1 What is pilot plant scale up? Discuss the significance and requirements for scale up of pharmaceutical

product from R and D to plant.

Q.2 What do you mean by the term “Technology Transfer”? Discuss in detail about WHO guidelines for

technology transfer.

Q.3 Define the term “Regulatory Affairs”. Discuss about role of regulatory affairs department and

responsibility of regulatory affairs professionals.

Part-C

Short answer questions. [5x7 = 35 Marks]

Note : Attempt any seven questions. Each question carries 5 marks.

Q.1 Discuss the concept of quality, total quality management and Quality by Design (QbD).

Q.2 Give a detailed account on regulatory requirements and approval procedures for new drug.

Q.3 Discuss general considerations of Investigational New Drug (IND) Application.

Q.4 Explain the role of biostatistics in pharmaceutical product development.

Q.5 Discuss in detail about ISO 9000 and ISO 14000 series of quality systems standards.

Q.6 Explain Technology transfer agencies in India

Q.7 Write a note on SUPAC guidelines

Q.8 Discuss Six Sigma concept and Management of clinical studies

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