Industrial Pharmacy II 7th Sem Question Paper With Answers

 

Industrial Pharmacy II 7th Sem Question Paper With Answers

Industrial Pharmacy II Question Paper is now available for you as a Industrial Pharmacy Model Question paper II For 2021. This question paper help you a lot of thing like pattern of exam and which type of questions asked in exams. So it is very good for you that we also include important and previous year Question paper also. Also You get Answers of these questions as in pdf uploaded after Some Time. So Please I request to study this question paper atleast in 10 Minutes to completely Understand this Industrial Pharmacy II Question Paper 7th Sem.

So Read This Question Paper and then download Answers Pdf of this question paper after 10 Minutes you Read and it will automatically downloaded.

               

BP–702-T
B. Pharm. SEMESTER VII
EXAMINATION, Feb., 2021
Subject : INDUSTRIAL PHARMACY II
Time : Three Hours ] [ Maximum Marks : 75
Note :Question paper is divided into two Sections 
A and B. Attempt both Sections. Answer 
questions as per instructions given.
Section—A
(Short Answer Type Questions)
Note : Attempt any five questions in about
150 words each. Each question carries
6 marks. (5×7=35)
1. Discuss the requirements of raw material, equipments and space for scaling up production of tablets.
Justify the need of training of personnel 
involved in scaling up technique. 
3. Discuss the characteristics of process and packaging material to be considered during technology transfer form R & D to production stage.
 
5. Define the following terms (any two) :
(i) Precession 
(ii) Accuracy 
(iii) Calibration 
(iv) Equipment qualification 
6. Discuss the role of central drug standard control organization as drug regulatory authority.
7. Explain the role of biostatistics in 
bioavailability and bio-equivalency estimation.
8. Discuss DMAIC and DMADV under six sigma concept of quality.
9. Define the significance of phase I and phase II investigation in out of specifications. 
10. Write down the concept of modules in 
common technical documents.
Section—B
(Long Answer Type Questions)
Note : Attempt any four questions in detail. Each question carries 10 marks. (4×10=40)
1. Write down the guidelines for scaling up post approval changes of modified release tablets. 
2. Discuss the role of technology information, forecasting and assessment council in technology transfer. Discuss in brief the related programs of TIFAC.
3. Discuss various types of investigational new drug applications. Describe various steps adopted for getting approval of IND.
4. Describe the procedure for transfer of analytical methods. 
5. Describe the role and responsibilities of regulatory affairs professionals. 
6. Explain the concept of pharmaceutical product quality. Describe the ISO certification guidelines for quality of product design and manufacturing.
7. Describe the process of drug approval and role of drug licensing authority in this process. 
8. Describe the requirements of technical persons, premises and equipment under good laboratory practices.

Let's Explain "Industrial Pharmacy II Question Papers" One By One

1) In first Question , firstly describe requirements of raw materials means the criteria or acceptance limits or quality of raw material required. then details about equipment used in production of tablet in large quantity. Scale up means large quantity production. 

2) This question is just a simple. Why training and practise required for scaling up techniques.

3) In this question, Give characteristics of of process and packaging material. You have know about packaging material used.

Then Write about technology transfer from R&D means Research and development to production storage.

5) Give definition of the the terms and explain how they are used in pharmaceuticals.

6) Write about the role of CDSCO (central drug standard control organization).It is a drug regulator authority. So give importance and roles with responsibility of  CDSCO.

7) this question is very simple means you have to write role of biostatistics in bioavailability estimation.

8) Explain what is six sigma and write about DMAIC and DMADV in points. This is important for quality purpose.

9) give a definition about phase 1 and phase 2 investigation. Then give her significance or application.

10) write about concept of nodules and how their role in technical documents.

Now Let's Start Section B Of "Industrial Pharmacy Question Papers of 7th Semester"

1) In this question firstly write about modified release Tablet's and then write how and guidelines about to post approval change in them but for scaling up.

2) This question is little bit tough. But if you about and if you readed about technology transfer. So you write about them.

3) firstly describe about investigational new drug application. And then write about how to get approval for them. and explain process of approval also.

4) This is very simple and easy question. Write about analytical method for transfer of technology.

5) In this question the first step is to write about Regulatory Affairs Professionals and then write her rules and responsibilities.

6)Write about pharmaceutical product quality and then write about ISO certification. Write all ISO certification with their functions.

7)In this question, you have write firstly about How to get Drug approval and then write what is role of drug licensing authority to give approval of drug.

8) Write about technical Staff and Equipment and premises required in good laboratory Practice.

Conclusion

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