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TQM – Quality Assurance Multiple Choice Questions with Answers B.Pharmacy 6th Semester

Quality Assurance Multiple Choice Questions (MCQs) with Answers Solved Question Paper 

1.      TQM stands for:

A.    Total quantity maintained

B.     Total quality management

C.     Total quantity measurable

D.    None of the above

2.      ICH Q 10 guidelines refer to:

A.    Pharmaceutical quality system

B.     Pharmaceutical product lifecycle management

C.     Development and manufacture of drug substances

D.    Stability testing of new drug substances

3.      ICH Q 1E guidelines refer to:

A.    Photostability testing of drug substances

B.     Evaluation of stability data

C.     Impurities in drug substances

D.    None of the above

4.      ICH E 11R1 guidelines refer to:

A.    Clinical investigation of medicinal products in the paediatric population

B.     Choice of control group in clinical trails

C.     Biomarkers related to drug or biotechnology products

D.    Genomic sampling

5.      ICH E 2E guidelines refer to:

A.    Pharmacovigilance planning

B.     Studies in support of special populations: Geriatrics

C.     Ethnic factors in the acceptability of foreign clinical data

D.    None of these

6.      In ICH guidelines, EWG means:

A.    Efficacy with generics

B.     Expert working group

C.     Effectiveness with generics

D.    None of the above

7.      ICH S10 guideline refers to:

A.    Photosafety evaluation of pharmaceuticals

B.     Rodent carcinogenicity testing for human pharmaceuticals

C.     Toxicokinetic evaluation

D.    None of the above

8.      Which of the following guideline deals with genotoxicity testing and data interpretation of pharmaceuticals for human use:

A.    S2 R1

B.     S3 A

C.     S3 B

D.    None of the above

9.      Biopharmaceutics Classification System-based Biowalvers is covered in:

A.    M9

B.     M7

C.     M1

D.    None of the above

10.  Which Module is region specific in CTD:

A.    Module 5

B.     Module 4

C.     Module 3

D.    Module 1

11.  ISO 9000 defines:

A.    Vocabulary related to improving various processes for customer quality

B.     Actions to be taken for process improvement

C.     Manpower requirement for quality improvement

D.    Premises requirement for process improvement

12.  ISO 14000 series of guidelines are related to:

A.    organizing and applying information about environmental management

B.     organizing manufacturing processes in sequence

C.     managing customer feedback on products

D.    None of the above

13.  GLP means:

A.    Good laboratory protocols

B.     Good laboratory practices

C.     Good laboratory planning

D.    None of the above

14.  If a foreign substance is found in a product, it can be termed as:

A.    Counterfeit

B.     Tampered

C.     Generic

D.    None of the above

15.  LOD in calibration means:

A.    Loss on drying

B.     Loss on defective product

C.     Limit of detection

D.    None of the above

16.  If a product has to be formulated with higher dose, it will undergo:

A.    Prospective validation

B.     Retrospective validation

C.     Revalidation

D.    Concurrent validation

17.  If data from previous batches is analysed to assess consistency of process:

A.    Concurrent validation

B.     Prospective validation

C.     Reworking

D.    Retrospective validation

18.  Double shelf system in materials management means:

A.    Supply time is half the purchasing interval

B.     Storing materials on top of each other

C.     Storing new and old materials in shelves

D.    None of the above

19.  Lead time with respect to material procurement means:

A.    Average time for using the issued materials

B.     Average time for disposing the unused materials

C.     Average time for ordering the materials

D.    Average time between placing an order and receipt of materials

20.  Reorder level is:

A.    Average consumption per day multiplied by one mouth 

B.     Average consumption per day multiplied by lead time

C.     Average material cost multiplied by number ordered

D.    None of the above.


Note: Any misspelling may be avoided in answers. Please Match with references.

1.       B

2.       A

3.       B

4.       A

5.       A

6.       B

7.       A

8.       A

9.       A

10.   D

11.   A

12.   A

13.   B

14.   D

15.   C

16.   C

17.   D

18.   A

19.   D

20.   B

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