JNTU
JNTU B.Pharmacy IV INDUSTRIAL PHARMACY-II Previous Question Paper (December – 2023 /January - 2024 - R17)
Note: i) Question paper consists of Part A, Part B. ii) Part A is compulsory, which carries 25 marks. In Part A, answer all questions. iii) In Part B, Answer any one question from each unit. Each question carries 10 marks and may have a, b as sub questions.
Part A
What is standard operating procedure?
Answer
A Standard Operating Procedure (SOP) is a set of written, step-by-step instructions compiled by an organization to help workers carry out complex routine operations. Its goal is to achieve efficiency, quality output, and uniformity of performance while reducing miscommunication and failure to comply with industry regulations.
What are the objectives and significance of pilot plants?
Answer
The primary objective of a pilot plant is to bridge the gap between laboratory-scale research and full-scale commercial production. Its significance lies in evaluating the feasibility of a manufacturing process, identifying potential production problems, optimizing process parameters, and ensuring that the final product meets quality standards before large-scale investment.
Abbreviate SIDBI.
Answer
Sign in to view the complete answer paper.
How analytical methods are exchanged in a technology transfer?
Answer
Sign in to view the complete answer paper.
What is investigational new drug and application?
Answer
Sign in to view the complete answer paper.
Define FDA and write the role of FDA in drug approval process.
Answer
Sign in to view the complete answer paper.
What is concept of quality? Explain.
Answer
Sign in to view the complete answer paper.
What is NABL? Explain its role.
Answer
Sign in to view the complete answer paper.
What is COPP?
Answer
Sign in to view the complete answer paper.
Write a note on common technical document.
Answer
Sign in to view the complete answer paper.
Part B
Discuss pilot plant scale up consideration for liquid orals.
Answer
Sign in to view the complete answer paper.
What are SUPAC Guidelines? Explain the SUPAC guidelines for immediate release dosage forms.
Answer
Sign in to view the complete answer paper.
Discuss stage involved in TT in pharmaceutical industry.
Answer
Sign in to view the complete answer paper.
Discuss granularity of TT process (API, excipients, finished products, packaging material) as per WHO guidelines for TT?
Answer
Sign in to view the complete answer paper.
Write a note on drug development team and their functions.
Answer
Sign in to view the complete answer paper.
Add a note on significance of biostatistics in pharmaceutical product development.
Answer
Sign in to view the complete answer paper.
Explain in brief about drug metabolism and toxicology.
Answer
Sign in to view the complete answer paper.
Explain the steps involved in protocol for conducting bioequivalence studies.
Answer
Sign in to view the complete answer paper.
Explain the concept of total quality management.
Answer
Sign in to view the complete answer paper.
Explain the concept of out of specifications.
Answer
Sign in to view the complete answer paper.
Write a note on change control.
Answer
Sign in to view the complete answer paper.
Explain in detail regarding ISO 9000 series of quality systems standards.
Answer
Sign in to view the complete answer paper.
Describe the functionalities of the Central Drug Standard Control.
Answer
Sign in to view the complete answer paper.
Explain in detail about Certificate of Pharmaceutical Product.
Answer
Sign in to view the complete answer paper.
Discuss the various Modules in CTD.
Answer
Sign in to view the complete answer paper.