B Pharm 6 Sem Quality Assurance Imp Questions 2024

In this post b pharm 6 semester quality assurance important questions are given for 2024. 

By solving these you can prepare for the exam and score good marks. In the questions given here, you will find many questions that have been asked continuously in the question papers for many years.

Therefore, there is a strong possibility of them being asked again in the upcoming examination.

Therefore, do not skip any questions of the pharmaceutical quality assurance Important questions given here and try to make the answer informative. 

If you have to write a brief answer to a question, then try to write an accurate and informative answer. 

It has been seen many times that the questions asked in the previous question paper are asked again and again in the examination. 

Therefore it is important to take these questions seriously. 

If you have any difficulty in writing or understanding the answers to the quality assurance important questions of 6th sem given here, then contact your professor. 

Before writing the correct answers, clear your concept on the quality assurance topic. 

For this, read the lessons related to this topic in your textbook 2 to 3 times and if necessary, also study the Advanced Pharma book. 

After that, you should try to write the answers to the 6th sem pharma quality assurance question bank given here in your own words, so that you can remember them easily.

Whenever you receive the quality assurance 6th sem question paper in the examination hall, ensure that the question paper received is error-free. 

This means that no page of the question paper should be missing or the question should not be misprinted. 

Start writing the answer only after getting confirmation of this. 

In case of any kind of error, inform the invigilator about it. 

Some instructions would have been given to you on the first page of the b pharm quality assurance 6th sem question paper received in the examination hall. 

Write the answer only after following them. 

That is, express your views in as many words as you have been instructed to write the answer and write an informative answer. 

With this, you will be able to give equal time to other questions also. 

Let's solve these questions and prepare excellent notes for yourself.


Quality Assurance Questions

Important Questions For B Pharm 6th Sem Quality Assurance

  • Write notes and discuss quality by design.
  • Write a note on the concepts and philosophy of GMP. How complaints should be handled according to the GMP provisions?
  • What are the general principles of analytical method development? 
  • How are sanitation and sterile areas maintained in pharmaceutical premises?
  • Write the quality control tests for plastic containers.
  • What is a Quality Audit? What is the scope of Quality Audit?
  • Compare the concept of QA and QC as per GMP.
  • Write at least five elements or criteria that are followed in the ISO 9000 series standards. What are the steps for the registration of ISO 9000?
  • Explain about recalling and waste disposal.
  • What criteria are applied for the selection, purchase, and maintenance of equipment?
  • Write a short note on QSEM with special emphasis on Q-series guidelines.
  • Write notes on the types of glasses used for manufacturing pharmaceutical containers.
  • Write a note on personnel responsibilities.
  • What is the need for distribution records in the industry?
  • Write a short answer on the following:- (a) Quality review (b) Overview of Qbd (c) General provision of GLP. 
  • Explain the importance of SOP in detail.
  • Discuss good warehousing practices.
  • Write a short note on NABL accreditation. Write the principles and procedures involved in NABL accreditation.
  • Explain the Testing facilities' operation and disqualification of testing facilities.
  • Discuss the Validation Master plan. Write short notes on Process validation and types of validation.
  • Describe the design, plant layout, maintenance, and sanitation of premises.
  • Write a short answer on the general principles of analytical method validity.
  • Describe the design, construction, and plant layout of the Pharmaceutical Industry.
  • Explain in detail about the Qualification of UV–a visible spectrophotometer.
  • Explain good laboratory practices.
  • Write short notes on the following:- (a) LOD (b) cGMP (c) Secondary packing materials (d) Quality documentation.
  • Write the comparison, accuracy, and precision of LOD and LOQ about ICH guidelines.
  • Explain the term 'ICH'. Write about the testing guidelines.
  • Discuss the calibration of the pH meter.
  • Write short notes on the following:- (a) Precision (b) LOQ (c) Raw materials (d) Training (e) Quality by design tools (f) Reports and documents.
  • Discuss total quality management.
  • Explain the standard operating procedure.
  • Explain the term Quality control.
  • Describe the process of harmonization of ICH guidelines.
  • Wrtie a short note on the hydrolytic resistance test for glass containers.
  • Discuss the protocol for conducting a nonclinical laboratory study.
  • Discuss the user requirement specification. Discuss equipment selection and purchase specifications.
  • Discuss the quality control tests for rubber closures.
  • Discuss the ISO 14000.
  • Give a brief account of product recall.
  • Write a short note on the following:- (a) Factory acceptance test (b) Control of contamination (c) Q-series guidelines (d) Handling of returned goods.
  • Describe the Batch Formula Record.
  • Discuss the quality control tests for glass containers.
  • Write in detail about the evaluation of complaints.
  • Write a short note on the following:- (a) Control articles (b) Roles of the head of the production department (c) Materials management.

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