B pharmacy 7 semester INDUSTRIAL PHARMACY Questions bank:
UNIT-1
2 MARKS Questions
- Define pilot and scale up?
- What is the difference between pilot scale and scale-up?
- Why to conduct pilot plant studies?
- What are the advantages of pilot studies?
- What is SUPAC?
- What is the purpose of SUPAC guidelines?
- Define platform technology?
5 MARKS short Assay
- What are the objectives and significance of pilot plants?
- Explain SUPAC guidelines?
- Discuss the uses of platform technology?
10 MARKS Long Assay
- Discuss the general factors to be considered in pilot plant scale up technology?
- Discuss pilot plant scale up consideration for solids dosage solids.
- Discuss pilot plant scale up consideration for liquid orals.
- Discuss pilot plant scale up consideration for semi-solids.
- what are difference platform technology and explain.
UNIT-2
2 MARKS SHORT ASSAY
- Define the technology transfer according to WHO and how it is classified?
- What are the goal of technology transfer?
- What are the advantage of technology transfer?
- What is good manufacturing practices (GMP)?
- What do you mean by SU &RU
- Define quality risk management (QRM) and write its principle
- What do you mean by intercompany and intracompany?
- What is standard operating procedure (SOP) ?
- What is validation and process validation?
- What is validation protocol (VP) and validation report (VR) ?
- what is the drug master file (DMF) ?
- What is analytical method transfer?
- What is design qualification (DQ) and installation qualification ( IQ) ?
- What is operational qualification (OQ) and performance qualification (PQ) ?
5 MARKS SHORT ASSAY
- Explain technology transfer sample protocol in pharmaceuticals
- Discuss technology transfer from R & D to production as per WHO guidelines?
- Discuss granularity of TT process (API, excipients, finished products, packaging material) as per WHO guidelines for TT ?
- Discuss about documentation, premises, and equipments for TT as per WHO guidelines
- Discuss about qualification and validation for TT as per WHO guidelines?
- How analytical methods are exchanged in a technology transfer ?
10 MARKS QUESTIONS
- Discuss stage involved in TT in pharmaceutical industry?
UNIT 3
2 MARKS QUESTIONS
- What is regulatory affairs ? what its goal?
- what is investigational new drug and application?
- what is New drug application (NDA) /
- what is clinical trial?
- what is clinical trial protocol?
- what are BE & BA studies? why they are required?
- Mention the major regulatory bodies in the world?
- What is the organisational structure of regulatory affairs ?
- Which is the health care product regulated by RA ?
- What is CTD ?
5 MARKS QUESTIONS
- Discuss the role and responsibilities of RA professional.
- Write a note on Drug development team and their functions.
- Discuss regulatory authorities and their responsibilities.
- Write a note on Non-clinical drug development process.
- Write a note on Investigator’s Brochure (IB).
- Discuss the different phase of clinical trial.
- How Bioequivalence are documented.
- Write a note on clinical Research protocol.
- Discuss about Management of clinical studies.
- Discuss the various Modules in CTD.
10 MARKS QUESTIONS
- Explain Regulatory Requirement Approval for obtaining NDA.
- Discuss general consideration of Investigational New drug Application.