KLE COLLEGE OF PHARMACY, BELAGAVI

A CONSTITUENT UNIT OF KLE ACADEMY OF HIGHER EDUCATION & RESEARCH, BELAGAVI [DEEMED-TO-BE-UNIVERSITY]
B. PHARM PROGRAM HAS BEEN ACCREDITED BY NBA FOR A PERIOD OF SIX YEAR (FROM JULY 2019 TO JUNE 2025)
SECOND INTERNAL ASSESSMENT EXAMINATION Program: BACHELOR OF PHARMACY (B. PHARM)
Semester: 6th Course: Pharmaceutical Quality Assurance Course Code: BP606T Max. Marks: 30
Date: 18/05/2023 Time: 03:00 PM to 04:30 PM Duration: 90 Mins Course In-charge: Mrs. Nisha Shirkoli

Q. No. MARKS CO BL
1 MCQs 10 3,4,5,6 L1
LONG ESSAY QUESTIONS (Answer Any One)
What is waste disposal? and explain different techniques of waste disposal in
2 10 6 L2
pharmaceutical industry.
3 Define validation and Give its Scope, Importance and Types. 10 5 L2

SHORT ESSAY QUESTIONS (Answer Any Two)

4 Explain types, evaluation and Handling of complaints pharmaceutical industry. 05 4 L2
Explain in brief stability studies and storage conditions of pharmaceutical packaging
5 05 3 L2
materials.
6 Explain Procedure for calibration of pH meter. 05 5 L2

COURSE OUTCOMES (COs)

BP606T.1 Outline the approaches & regulatory guidelines of quality management in pharmaceutical industry and
accreditation processes.
BP606T.2 Discuss the role of Personnel, Premise design, selection & maintenance of equipment and raw materials
in accordance to Good Manufacturing Practices.
BP606T.3 Discuss principle, procedures and applications of Good Laboratory Practices in pharmaceutical industry
BP606T.4 Outline the various documents to be maintained for quality audits.
BP606T.5 Discuss the principles of calibration, validation and qualification of equipment and analytical methods
used in pharmaceutical industry.
BP606T.6 Describe the procedure for handling of complaints & return goods, product recalling and waste disposal.

BLOOMS TAXONOMY LEARNING LEVEL (BL)

L1: Remember L2: Understand L3: Apply L4: Analyze L5: Evaluate L6: Create

PROGRAM OUTCOMES (POs)

1 Pharmacy Knowledge 5 Leadership skills 9 The Pharmacist and Society
2 Planning Abilities 6 Professional Identity 10 Environment and Sustainability
3 Problem Analysis 7 Pharmaceutical Ethics 11 Life-long Learning
4 Modern Tool usage 8 Communication
 KLE COLLEGE OF PHARMACY, BELAGAVI
A CONSTITUENT UNIT OF KLE ACADEMY OF HIGHER EDUCATION & RESEARCH, BELAGAVI [DEEMED-TO-BE-UNIVERSITY]
B. PHARM PROGRAM HAS BEEN ACCREDITED BY NBA FOR A PERIOD OF SIX YEAR (FROM JULY 2019 TO JUNE 2025)
SECOND INTERNAL ASSESSMENT EXAMINATION Program: BACHELOR OF PHARMACY (B. PHARM)
Semester: 6th Course: Pharmaceutical Quality Assurance Course Code: BP606T Max. Marks: 30
Date: 18/05/2023 Time: 03:00 PM to 04:30 PM Duration: 90 Mins Course In-charge: Mrs. Nisha Shirkoli

Q. 1. MCQs (10 Minutes) (10 Marks) Answer

i. Size of the Equipment is decided based on the______ of materials.
A. Chemical Composition B. Volume
C. Nature D. None of these
ii. Person handling complaint should be from ___________ department.
A. R & D B. Packaging
C. Quality management D. Production
iii. Premises should be of suitable size and construction to facilitate ___________.
A. Cleaning B. Storage
C. Maintenance D. All
iv. The purpose of DQ is to check the __________.
A. Installation B. Design
C. Performance D. Operation
v. ____________ department should evaluate all aspects of the received material.
A. R and D B. QA
C. Production D. QC
vi. An entity which commissions, supports and/or submits a non- clinical testing study is__________
A. Study Director B. Principal Investigator
C. Sponsor D. Study Personal
vii. Calibration minimizes uncertainties by assuring the _________ of the equipment.
A. LOD B. Accuracy
C. LOQ D. Robustness
viii. Document can be a piece of _____________ matter.
A. Written B. Printed
C. Electronic D. All of these
ix. In water vapor permeability test each container is allowed to stand for __________ days.
A. 28 B. 10
C. 30 D. 14
x. Water attack test is only used for __________ glass containers.
A. Type I B. Type II
C. Type III D. Type IV
 KLE COLLEGE OF PHARMACY, BELAGAVI
A CONSTITUENT UNIT OF KLE ACADEMY OF HIGHER EDUCATION & RESEARCH, BELAGAVI [DEEMED-TO-BE-UNIVERSITY]
B. PHARM PROGRAM HAS BEEN ACCREDITED BY NBA FOR A PERIOD OF SIX YEAR (FROM JULY 2019 TO JUNE 2025)
SECOND INTERNAL ASSESSMENT EXAMINATION Program: BACHELOR OF PHARMACY (B. PHARM)
Semester: 6th Course: Pharmaceutical Quality Assurance Course Code: BP606T Max. Marks: 30
Date: 18/05/2023 Time: 03:00 PM to 04:30 PM Duration: 90 Mins Course In-charge: Mrs. Nisha Shirkoli

Q. No. MARKS CO BL
1 MCQs 10 3,4,5,6 L1
LONG ESSAY QUESTIONS (Answer Any One)
2 Explain in detail different test for glass containers. 10 3 L2
3 Define qualification and explain DQ, IQ, OQ, and PQ. 10 5 L2

SHORT ESSAY QUESTIONS (Answer Any Two)

4 Explain principle and process involved in Analytical Validation. 05 5 L2
5 Explain in detail about Recall Procedure. 05 6 L2
6 Explain SOP and BMR. 05 4 L1

COURSE OUTCOMES (COs)

BP606T.1 Outline the approaches & regulatory guidelines of quality management in pharmaceutical industry and
accreditation processes.
BP606T.2 Discuss the role of Personnel, Premise design, selection & maintenance of equipment and raw
materials in accordance to Good Manufacturing Practices.
BP606T.3 Discuss principle, procedures and applications of Good Laboratory Practices in pharmaceutical industry
BP606T.4 Outline the various documents to be maintained for quality audits.
BP606T.5 Discuss the principles of calibration, validation and qualification of equipment and analytical methods
used in pharmaceutical industry.
BP606T.6 Describe the procedure for handling of complaints & return goods, product recalling and waste
disposal.

BLOOMS TAXONOMY LEARNING LEVEL (BL)

L1: Remember L2: Understand L3: Apply L4: Analyze L5: Evaluate L6: Create

PROGRAM OUTCOMES (POs)

1 Pharmacy Knowledge 5 Leadership skills 9 The Pharmacist and Society
2 Planning Abilities 6 Professional Identity 10 Environment and Sustainability
3 Problem Analysis 7 Pharmaceutical Ethics 11 Life-long Learning
4 Modern Tool usage 8 Communication
 KLE COLLEGE OF PHARMACY, BELAGAVI
A CONSTITUENT UNIT OF KLE ACADEMY OF HIGHER EDUCATION & RESEARCH, BELAGAVI [DEEMED-TO-BE-UNIVERSITY]
B. PHARM PROGRAM HAS BEEN ACCREDITED BY NBA FOR A PERIOD OF SIX YEAR (FROM JULY 2019 TO JUNE 2025)
SECOND INTERNAL ASSESSMENT EXAMINATION Program: BACHELOR OF PHARMACY (B. PHARM)
Semester: 6th Course: Pharmaceutical Quality Assurance Course Code: BP606T Max. Marks: 30
Date: 18/05/2023 Time: 03:00 PM to 04:30 PM Duration: 90 Mins Course In-charge: Mrs. Nisha Shirkoli

Q. 1. MCQs (10 Minutes) (10 Marks) Answer

i. The design of the equipment should be according to its____
A. SOP B. URS
C. Working D. None of These
ii. In powdered glass test ___________ indicator is used.
A. Eriochrome black T B. Methyl Orange
C. Methyl Red D. Phenolpthalein
iii. Subpart B of GLP deals with ___________.
A. Organization and Personnel B. General Provisions
C. Records and Reports D. Facilities
iv. Which of the following relates to the Good Laboratory Practice (GLP) guideline under the Drugs and
Cosmetics Rules, 1945?
A. Schedule M B. Schedule M1
C. Schedule L D. Schedule L1
v. Distribution records shall contain ___________ of the product.
A. Name B. Strength
C. Both of these D. None of These
vi. Materials management is a scientific technique concerned with _________ of flow of materials.
A. Planning B. Controlling
C. Organizing D. All of These
vii. The prevention of Cruelty to Animal Act was passed in____
A. 1950 B. 1957
C. 1960 D. 1967
viii. Subpart E of GLP deals with
A. Testing Facilities Operation B. Records and Reports
C. Organization and Personnel D. Test and Control Articles
ix. Water attack test is only used for __________ glass containers.
A. Type I B. Type II
C. Type III D. Type IV
x. Which of the following should be avoided during the feed of laboratory Animals?
A. Perishable items such as meats, fruits and B. Contaminated Food
vegetables
C. Crude Fiber D. All of the above