industrial pharmacy Part-2



Industrial pharmacy

SET -1 Mcq on industrial pharmacy

1.Clinical hold period to start from IND submission to human trial is -----
A. 30 day
B. 45 day 
C. 60 day
D. 6 months

ANSWER: A

2.NOAEL is 
A. No Observed Additive Effect limit
B. No Observed Adverse Effect Level
C. No observable adjunct efficiacy limit
D. None of the above


ANSWER: B

3.Criteria for Fast Track drug development include
A. Demonstrate potential to address unmet medical needs
B. Intends to treat serious & life threatening conditions
C. Intends to treat serious side effects of therapy
D. All of the above 


ANSWER: D

4.FDA submission now requires eCTD format of document submission which means
A. Eletcronic Common Technical Document
B. Electrical Common Technical Document
C. Electronic comittee Technical Document
D. None of the above 


ANSWER: A


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


ANSWER: C

6.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 

7.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

8.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

9.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

10.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

SET -2 Mcq on industrial pharmacy

11.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

12.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

13.Quality control is defined as ……
A. Sampling and documentation
B. Sampling, specification and documentation
C. Sampling, specification, testing, documentation and release procedures
D. None of these


ANSWER: C

14.ICH guidelines involve ……
A. Quality, Safety
B. Quality, Safety and Efficiency
C. Quality control and Multidisciplinary guidelines
D. Quality, Safety, Efficiency and Multidisciplinary guidelines


ANSWER: D

15.Carcinogenicity and Genotoxicity study is a …… aspect of ICH guidelines.
A. Safety guidelines 
B. Efficiency guidelines
C. QSEM guidelines
D. All of these


ANSWER: A

16.Pharmacovigilance is a part of ……
A. ICH E1 guidelines 
B. ICH E3 guidelines
C. ICH E2 guidelines 
D. ICH E2 (A-F) guidelines


ANSWER: D

17.Key components of TQM are ……
A. Consumer/Customer focus 
B. Continuous improvement
C. Involvement of employee 
D. All of these


ANSWER: D

18.Six sigma concept includes ……
A. Define, Measure, Analyze, Improve and Control
B. Design, Measure, Analyze, Improve and Control
C. Define, Manage, Analyze, Improve and Control
D. All of these


ANSWER: A

19.The basic principle of ISO 9000 is ……
A. Customer focus and Engagement of people
B. Relationship management and Leadership
C. Evidence based decision making and Continuous improvement
D. All of these


ANSWER: D

20.ISO 14000 relies on …….
A. DMAIC model 
B. PDCA model
C. Six-sigma concept 
D. All of these


ANSWER: B

21. Guidelines for Environmental performance evaluation are included in ……
A. ISO 14004 
B. ISO 14001
C. ISO 14040 
D. ISO 14031
ANSWER: D

industrial pharmacy part -1

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