Total Pages : 3

PC-656/MJ
F-3/2051
QUALITY ASSURANCE
Paper – BP-606T
Semester-VI

Time : Three Hours] [Maximum Marks : 75

Note : Attempt any two questions from Section-A any seven

questions from Section-B and all questions from
Section-C.

SECTION – A
I. What is ICH? What is the purpose of ICH guidelines?
Explain briefly the various categories of ICH guidelines.
Enlist various ICH Quality guidelines. Discuss the ICH
stability testing guidelines. (10)

II. Define Good Laboratory Practices (GLP). What are the

objectives of GLP? Discuss the GLP provisions regarding
the Organization and Personnel, Facilities, Equipment and
testing facilities. (10)

III. Discuss the role of quality assurance department in

equipment selection, framing purchase specifications,
maintenane of stores and raw materials. (10)
656-MJ/PDF/HHH/904 [P.T.O.
 SECTION – B
IV. Differentiate between quality control and quality
assurance. (5)

V. Write an account on TQM. (5)

VI. What is GMP and cGMP? Discuss the benefits of GMP in

pharmaceuticals. (5)

VII. Define calibration. Discuss the characteristics of

calibration. (5)

VIII. What is Master Formula Record? Give its contents. (5)

IX. What is product recall? Explain procedure of product

recall. (5)

X. Write an account on general principles of analytical method

validation. (5)

XI. Discuss good warehousing practices. (5)

XII. Enlist various quality control tests on containers. Explain

hydrolytic resistance test on glass. (5)

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 SECTION – C
XIII. Write brief notes on the following :

(a) SOP.

(b) Quality by Design.

(c) Quality Audit.

(d) Accreditation.

(e) Installation Qualification (IQ).

(f) Batch Formula Record.

(g) Performance Qualification. (PQ)

(h) NABL.

(i) ISO 14000.

(j) Contamination control in Sterile Area. (2×10=20)

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