industrial pharmacy 2 question bank

industrial pharmacy 2 question bank | Industrial pharmacy b pharm 7th semester imp que welcome friends here are the important questions for industrial pharmacy – II subject of 7th semester.

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IP – II b pharm 7th sem imp que

Below given are the list of most important questions for industrial pharmacy 2 subject:

B. PHARMACY DEGREE EXAMINATION

PCI PATTERN SEMESTER – VII

INDUSTRIAL PHARMACY – II

Discuss general considerations of Investigational new drug application.
Discuss about documentation, premises and equipments for TT as per WHO guidelines.
What is full form of SUPAC guideline? Discuss its application and significance.
Write a note on clinical research protocol.
Discuss total quality management.
Biostatistics in Pharmaceutical product development.
Regulatory requirement of bioequivalence studies.
Describe the clinical trial protocol.
Explain the procedure for pilot plant scale-up for liquid orals.
Explain technology transfer form R & D to production as per WHO guidelines.
Organizational structure of regulatory affairs.
Explain in brief concept of quality by design.
What is CDSCO explain.
Define finished pharmaceutical product.
Define Six sigma. • TT agencies in India.
COPP. • State licensing Authority.
What is quality control?
What is Good Manufacturing Practices?
What is qualification and validation?
Why to conduct pilot plant studies?
Explain the procedure for pilot plant scale-up semisolid dosage form
Define technology transfer .what is sending unit and receiving unit?
Write the WHO Guidelines for technology transfer.
What are the regulatory requirements and approval procedures for new drugs?
Write briefly on the Technology Transfer (TT) process for finished product
Write a note on Drug Master Files
Discuss NDA regulatory approval process with suitable examples • Write a short note on Investigator’s Brochure (IB).
Write a short note on post marketing surveillance
Write a short note on management Of clinical studies
SUPAC Guidelines.
Discuss the role and responsibility of regulatory affairs.
Analytical method Technology Transfer.
What are BE & BA studies?
What are the advantages of pilot plant studies?
Advantages of technology transfer.
What is the purpose of pre-clinical testing? What is Good Laboratory Practices?
National Research Development Corporation (NRDC).
What do you mean by ANDA?
Define clinical research. • Quality by Design (QbD)
Define In-process control. (a) Define pilot plant. Explain the difference between pilot batch and exhibit batch. (b) Differentiate between independent and dependent variables with examples. (c) Explain the basic principle of fluid bed process. (d) Give cone and coat properties for the microencapsulation. (e) What are pressurized packages ? Explain its principle of operation. (f) Define leachables and extractables with examples. (g) Discuss the formulation aspects of pellets.
Explain the significance and requirement of pilot plant. (b) Discuss the scale-up considerations of injectables.
Explain polymerization method of microencapsulation.
Discuss the challenges in formulation of suspension type aerosols. Give one prototype formulation.
Define optimization. Discuss in detail simplex method.
Explain Lagrangian method of optimization.
Give the advantages and disadvantages of plastic as a packaging material.
Explain phenomenon of sorption with respect to rubber closures as a packaging material.
Discuss in detail key attributes of production and process control.
Comment on CGMP for buildings and facilities.
Write short notes on : (a) Industrial hazards (b) Extrusion/spheronization method (c) Evaluation of microcapsules (d) Quality control of aerosols.
Mention two major applications of platform technology.
Mention the basic role of SUPAC guidelines.
Name at least 4 agencies responsible for successful technology transfer in India.
State the role of one major TT agency of India.
State to important functions of the Regulatory Affairs Department.
What do you mean by ‘Non-Clinical Drug Development’?
What do you mean by ‘Six Sigma concept,’?
Mention the specifications of ISO 14000 series of quality systems standards.
State the responsibilities of CDSCO.
Mention the significance of COPP.
State and explain the Technology transfer protocol following WHO guidelines.
Describe the steps of data presentation for FDA Submissions.
Give a brief idea on regulatory requirements and approval procedures for new drugs.

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Explain the significance of personnel requirements in pilot plant scale up.
Describe the steps for technology transfer from RD to production.
State and explain the legal issues during technology development and transfer.
Explain the responsibilities of the regulatory affairs professionals.
Define clinical research and state the clinical research protocols.
Write a brief note on the concept of Quality by Design (QbD).
Describe the functionalities of the Central Drug Standard Control.

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