First Sessional Exam.

BP 606T:
Pharmaceutical Quality Assurance
(B.Pharm VI A+B)

1. Which department is responsible for evaluation of batch records?

(1 Point)

QC

Both QA & QC

None of the given options

QA

2. Validation protocol consists of:

(1 Point)

A description of the sampling procedures

Schedule or criteria for revalidation

A description of the process, equipment or method to be validated

All of the given options

3. The finished product containing active ingredients should comply with

_______________ composition of the marketing authorization.
(1 Point)

Qualitative
 Quantitative

None of the given options

Qualitative & Quantitative

4. QC activities focus on identifying _______ in actual product produced.

(1 Point)

Defect

Both Defect & strength

None of the given options

Strength

5. Providing documented evidence that a method/product does what it intends to

do is termed as?
(1 Point)

Assurance

Qualification

Validation

Calibration

6. Which of the following is building block of TQM?

(1 Point)

All of the given options

Training

Teamwork

Leadership
 7. Which of the following is an important aspect of Equipment validation?
(1 Point)

Process Qualification

Instructional Qualification

Performance Qualification

Process Validation

8. The scope of sanitation and hygiene covers _______________.

(1 Point)

Equipment

All of the given options

Premises

Personnel

9. Design qualification should be perform with a new ______________

(1 Point)

Validation

SOP

Equipment

Procedure

10. The purpose of ICH is to make recommendations on the ways to achieve

greater:
(1 Point)

Harmonization

Quality
 Optimization

Safety

11. TQM aims at long term success through:

(1 Point)

Owner satisfaction

All of the given options

Management Satisfaction

Customer satisfaction

12. The reagents used for controlling the absorbance during UV-
Spectrophotometer calibration are
(1 Point)

1.2 % V/V Potassium chloride

All of the given options

1.4 M Perchloric acid and Holmium Oxide

0.005 M Sulphuric acid and Potassium dichromate

13. A high level of personal hygiene should be followed and observed by all those
concerned with _________________ processes.
(1 Point)

Transporting

None of these

Warehousing

Manufacturing
14. The pH electrode is stored in saturated solution of
(1 Point)

KCl

NaCl

NH4Cl

HCl

15. The type of process validation which is based on information generated during
actual implementation of the process or during production is known as
_______________.
(1 Point)

Concurrent validation

Retrospective validation

Prospective validation

Analytical validation

16. To approve or reject the starting materials, packaging materials and

intermediate, bulk and finished product is responsibility of which department?
(1 Point)

QA

QC

All of the given options

Production

17. According to WHO, QC is a part of:

(1 Point)

GLP
 GCP

None of these

GMP

18. TQM is a description of:

(1 Point)

Organization

Attitude

All of the given options

Culture

19. Quality is a degree of:

(1 Point)

Excellence

Agreement

Risk

Maintenance

20. Which one of the following is the characteristic of the spectrum obtained in UV-
Spectrophotometer
(1 Point)

Sharp peak

Wide peak

Double shoulder peak

Two sharp peaks

21. To identify and prepare the necessary SOP’s related to control of quality is a
responsibility of _____________ department.
(1 Point)

Production

All of the given options

QC

QA

22. During UV- Spectrophotometer qualification, the resolution power of the

instrument is determined at ________ and ___________ wavelengths.
(1 Point)

313 nm and 350 nm

269 nm and 266 nm

200 nm and 430 nm

235 nm and 257 nm

23. GMP ensures which of the following parameters?

(1 Point)

Quality

Efficacy

All of the given options

Safety

24. A validation process is one which has been demonstrated to provide a

(1 Point)

High degree of precision

None of these
 High degree of assurance

High degree of linearity

25. The acceptance criteria for the limit of stray light is

(1 Point)

None of the above

Absorbance ratio at 269 nm should be not less than 1.5

Absorbance should be in the limit ± 0.5

Absorbance at 200 nm should be greater than 2

26. Calibration of an instrument is the process of determining its

(1 Point)

Tracebility

Precision

Accuracy

Linearity

27. During calibration of pH meter, the buffers of different pH used are

(1 Point)

None of the above

Only pH 10

Only pH 4

pH 4 and pH 10

28. The purpose of IQ is to check the _____________.

(1 Point)
 All of the given options

Installation

Performance

Design

29. Retrospective validation is based upon

(1 Point)

Review and analysis of historical data

Data generated during production

Change of formula, equipment, procedure or quality of raw material

Data generated during the product development stage

30. Which of the following department holds responsibility of Quality monitoring?

(1 Point)

Strength

Purity

All of the given options

Identity

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