T.Y.B.Pharmacy sem. VI Second Sessional examination Pharmaceutical Quality Assurance (BP606T)

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T.Y.B.Pharmacy
Distribution of Marks
MCQs: 20M
True or False: 05M
Match the pair : 05M
Total : 30M

Name of Student *

PRN no. *

Roll no: *

1. Amount of alkali leached from the glass is determined in the test___________ *

1 point

Test of Arsenic

Hydrolytic Resistance Test

Thermal shock test

Leakage test

2. Folding endurance is the test applicable to________ *

1 point

Paper boards

Cartons

Boxes

All of them

3. Identify the test which is not Q.C test of rubber closures. *

1 point

Self-sealability

light absorption

Residue on evaporation

Collapsibility test

4. Identify the subpart E of the GLP *

1 point

General Provisions

Organization and Personnel

Equipment

Testing facilities operation

5. Any material derived from a test system for examination or analysis is known as____ *

1 point

Testing facility

Specimen

Raw data

All of the above

6. Identify the main points to be considered in GLP *

1 point

Rules and protocols

Quality assurance

Resources

All of the above

7. Individual responsible for overall conduct of a non clinical laboratory study is known to be________ *

1 point

Quality Assurance Unit

Sponsor

Study director

Head of Production department

8. Which of the following are GLP regulations or requirements? *

1 point

21CFR58

40CFR171

both a&b

21CFR 180

9. Water attack test is used as quality control control test for________ *

1 point

Glass

Plastic

Rubber

Metal

10. A container fitted with a device or mechanism that reveals irreversibly whether the container has been opened is called as______ *

1 point

Single-dose container

Tightly-closed container

Tamper-evident container

Well-closed container

11. Standard Operating Procedure (SOP) refers to *

1 point

An optimal balance between possibilities realized and a framework of norms and values.

Doing the right thing right, right away, the first time

Detailed, written instructions to achieve uniformity of the performance of a specific function.

A process of meeting the needs and expectations of the customers,both internal and external.

12. Color code used for the labels goods showing the status of approved is______ *

1 point

Green

Yellow

Red

Orange

13. An organization being audited is called as *

1 point

Auditor

Auditee

both a and b

inspector

14. Identify the appropriate reason for recall of goods *

1 point

negative results from the ongoing stability testing

After warning of regulatory inspection

On confirmation of complaint

All of the above

15.Requirement of record & Reports are as per_______ *

1 point

21CFR section 180

21CFR section 181

40 CFR section 180

21CFR section 57

16.Conduction of Audit in the organization ensures *

1 point

the level of compliance

Monitor improvement

gives validation plan

both A and B

17.How long the complaint file should be retained after expiry date of the lot *

1 point

2 years

b. 180 days

c. 1 year

d. 5 year

18. waste containing chemicals are classified as *

1 point

Hazardous waste

Non-hazardous waste

Chemo waste

pharmaceutical waste

19. MFR should contain *

1 point

weight of product

Name, logo and address of the manufacturing company.

Description of drug product containers

All of the above

20. When the retained sample is within the specification but the complaint sample is out of specification, the case is known as *

1 point

confirmed complaint

counterfeit suspicion

non-confirmed complaint

all of the above

21. Validation ensure the consistency and reproducibility of the manufacturing operation *

1 point

True

False

22. Corrective action and Preventive actions are not taken on receiving the complaint *

1 point

True

False

23. Good documentation practices state: Dates are not required, and it's ok to backdate stuff. *

1 point

True

False

24. Good documentation practices state: Signing for other people is ok *

1 point

True

False

25.The time required and costs involved in an external audit are much higher as compared to internal audits. *

1 point

True

False

26. Match the pairs according to the Q.C tests to be performed *

5 points

Collapsibility test

Folding endurance

surface hydrolytic resistance

Eye irritancy test

Self-sealability

Glass

Plastic

Rubber closure

Paper boards

Containers for eye preparations

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