industrial pharmacy Part -1



Industrial Pharmacy

SET 1 :- Mcq on the industrial Pharmacy 

1.    Following are the objectives of pilot plant & scale-up studies except
A.    To identify the critical features of the process
B.    To avoid the future scale-up problems.
C.    To provide master manufacturing formula with instructions for manufacturing procedure
D.    To guess the market sale
ANSWER: D

2.    Importance of pilot plant include all of the following except
A.    Idea about process requirements
B.    The specification of the raw materials
C.    Examination of formulae 
D.    Assurance of approval
 

ANSWER: D

3.    Following are the important stages in scale-up process
A.    Define product economics
B.    Scale up planning and defining rate controlling steps
C.    Larger than laboratory studies
D.    All of the above
 

ANSWER: D

 

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4.    Generally, reporting head for scale-up studies 
A.    R& D head or Formulator who developed product 
B.    QC department
C.    Management 
D.    None of the above
ANSWER: A

5.     Which of the following is not a scale-up process?
A.    Laboratory to pilot-scale
B.    Pilot-scale to industrial-scale
C.    Industrial to pilot-scale 
D.    Laboratory to industrial-scale


ANSWER: C

6.    Pilot plant can be used for ……
A.    Evaluating results for laboratory studies
B.    Product and process correction
C.    Shelf life and stabilities studies
D.    All of the Abve


ANSWER: D

7.    What does the need of Contract Research Organization reflects?
A.    A desire for the pharma companies to build their in-house development capability
B.    The desire to reduce competition with smaller biotech companies
C.    The pharma company trying to reduce its fixed investment in development by buying CROs
D.    A pharma company's desire to balance control over drug development with fluctuations in workload


ANSWER: D

8.    Which of the following methods are generally used in liquid filling?
A.    Gravimetric
B.    Volumetric
C.    Constant level method
D.    All of the above
ANSWER: D

9.    The filling method of a pharmaceutical liquid depends on the following factors ……
A.    Viscosity of the liquid
B.    Surface tension of the liquid
C.    Compatibility with the material used in the construction of the filling machine
D.    All of the above


ANSWER: D

10.    MoU stands for …….
A.    Memorandum of Ubiquitous 
B.    Memorandum of Understanding
C.    Memorandum of Unpredictable
D.    Memorandum of Unprofitable


ANSWER: B

SET 2 :- Mcq on the industrial Pharmacy 

11.    The transfer of technology between sites of different companies is called as …….
A.    Inter-company transfer 
B.    Intra-company transfer
C.    Technology transfer
D.    Technology transfer protocol


ANSWER: A

12.    The basic requirement of Technology Transfer is …….
A.    Technology Receiver 
B.    Technology Giver
C.    Both (a) and (b) 
D.    None of these


ANSWER: C

13.    The definition of Quality Risk Management (QRM) has been mentioned in ICH guideline …….
A.    Q7 
B.    Q8
C.    Q9 
D.    Q10
ANSWER: C

14.    For liquid dosage form, which information to technology transfer?
A.    Range of pH and viscosity
B.    Specific gravity
C.    H2O content 
D.    All of these


ANSWER: D

15.    Installation Qualification (IQ) is …….
A.    A documented verification of the proposed design of the facilities, systems and equipment
B.    An evidence of all key aspects of the process equipment and ancillary system installation
C.    Objective evidence process for the control limits and action levels in product of all predetermined requirements
D.    Verifying a process, under anticipated condition, consistently produces a product which meets all predetermined requirements


ANSWER: B

16.    Who are the study leaders based at each site during the clinical trial?
A.    Chief medical officer and clinical research associates
B.    Principal investigators and study coordinates
C.    Study coordinates and chief medical officer
D.    Principal investigators and clinical research associates


ANSWER: B

17.    What is the purpose of the case report form?
A.    To ensure data accuracy by providing a place to store warehouse patient data for audit purposes
B.    To provide a reference for all study subjects from which to analyze patient data.
C.    To include in the NDA filing.
D.    All of above
ANSWER: D

18.    What is the primary focus of Phase 3 Clinical testing?
A.    How to manage costs.
B.    The collection and analysis of highly specific efficacy end-point data
C.    The optimal range of effective dosage.
D.    The analysis of data results from the small-subset target population


ANSWER: B

19.    On which two criteria does the FDA classify NDAs?
A.    Novelty of the active ingredient and time to market
B.    Balance between safety and effectiveness
C.    Novelty of the active ingredient and clinical improvement
D.    Clinical improvement and effectiveness of product 


ANSWER: C

20.    Quality management system deals with ……
A.    Quality for their products and services
B.    Safety for their products and services
C.    Quality and safety for their products
D.    Quality and safety for their products and services


ANSWER: C

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