MCQs - INDUSTRIAL PHARMACY ll

INDUSTRIAL PHARMACY ll

BP702TT

B.PHARMA SEMESTER 7

1. Pilot Plant Scale-Up Techniques

1. 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

2. 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 above

3. What does the expansion in CRO's reflect?

(a) A pharma company's desire to balance control over drug development with fluctuations in workload.

(b) The pharma company trying to reduce its fixed investment in development by buying CROs.

(c) The desire to reduce competition with smaller biotech companies.

(d) A desire for the pharma companies to build their in-house development capability.

4. Which of the following methods are generally used in liquid filling?

(a) Gravimetric 

(b) Volumetric

(c) Constant level method

(d) All the above

5. 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 the above

2.TECHNOLOGY DEVELOPMENT AND TRANSFER

1. MoU stands for …….

(a) Memorandum of Ubiquitous 

(b) Memorandum of Understanding

(c) Memorandum of Unpredictable

 (d) Memorandum of Unprofitable

2. 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

3. The basic requirement of Technology Transfer is …….

(a) Sending Unit (SU) 

(b) Receiving Unit (RU)

(c) Both (a) and (b) 

(d) None of these

4. The definition of Quality Risk Management (QRM) has been mentioned in ICH

guideline …….

(a) Q7 

(b) Q8

(c) Q9 

(d) Q10

5. For liquid dosage form, which information is provided by SU to RU?

(a) Range of pH and viscosity

 (b) Specific gravity

(c) H2O content 

(d) All of these

6. Small industrial Development Bank of India (SIDBI) was established on …….

(a) April 2, 1990

 (b) April 2, 1991

(c) April 2, 1992 

(d) April 2, 1993

7. Installation Qualification (IQ) is …….

(a) A documented verification of the proposed design of the facilities, systems and

equipments.

(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.

8. The discipline of any organization involved in transferring of designated process or

method is called as …….

(a) SU 

(b) RU

(c) QRM 

(d) None

3. REGULATORY AFFAIRS & REGULATORY REQUIREMENTS FOR DRUG APPROVAL

1. 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.

2. 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.

3. At the end of the study, what happens to the case report forms (CRFs)?

(a) The CRF data is compiled and submitted to the FDA in the IND.

(b) The CRF data is aggregated by an external party if the trial was double blinded to

assess the drug's safety and efficacy.

(c) The CRF data is aggregated and analyzed to assess the drug's safety and efficacy.

(d) The CRF data is compiled and submitted to Regulatory Affairs

4. 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

5. 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

4. QUALITY MANAGEMENT SYSTEMS

1. 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

2. 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

3. ICH guidelines involve ……

(a) Quality, Safety

(b) Quality, Safety and Efficiency

(c) Quality control and Multidisciplinary guidelines

(d) Quality, Safety, Efficiency and Multidisciplinary guidelines

4. Carcinogenicity and Genotoxicity study is a …… aspect of ICH guidelines.

(a) Safety guidelines 

(b) Efficiency guidelines

(c) QSEM guidelines

(d) All of these

5. Pharmacovigilance is a part of ……

(a) ICH E1 guidelines 

(b) ICH E3 guidelines

(c) ICH E2 guidelines 

(d) ICH E2 (A-F) guidelines

6. Key components of TQM are ……

(a) Consumer/Customer focus 

(b) Continuous improvement

(c) Involvement of employee 

(d) All of these

7. 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

8. 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

9. ISO 14000 relies on ……

(a) DMAIC model 

(b) PDCA model

(c) Six-sigma concept 

(d) All of these

10. Guidelines for Environmental performance evaluation is included in ……

(a) ISO 14004 

(b) ISO 14001

(c) ISO 14040 

(d) ISO 14031