Industrial Pharmacy II — Summer 2025

Explain the type of changes applicable under SUPAC IR guidelines.

Enlist and explain consideration for pilot plan scale-up for oral solid dosage form.

Explain in details factors to be considered for technology transfer from research and development to production in pharmaceutical industry.

Explain in detail various phases of a technology transfer project.

Write a note on the role and responsibilities of regulatory affairs professionals in pharmaceutical industries.

Define IND. Explain various types of IND according to the US FDA with suitable examples.

Explain the content and importance of the Investigator’s Brochure (IB) in clinical studies.

Explain the concept of Quality by Design (QbD) with respect to the development of pharmaceutical products.

Write a note on the scope and importance of accreditation under NABL in India.

Explain the organizational structure and function of CDSCO.

Explain the composition and function of state-level regulatory agencies for pharmaceutical products in India.

Explain the quality management principles related to ISO 9000 series.

Write a note on regulatory requirements and approval procedures for New Drugs in India

What is the Six Sigma concept? Explain the characteristics, objectives and principles of Six Sigma in the context of the pharmaceutical industry.

Explain in detail important aspects of technology transfer agreements for pharmaceutical products. Q. 6 (a) Explain non-clinical studies for new drug development.

Write a note on the function of TIFAC in the context of technology transfer.

Write a note on platform technology with respect to pharmaceutical products with suitable examples.

Write a note on the significance of space requirement for scale-up techniques.

Discuss confidentiality agreements in Technology Transfer.

What is quality risk management system? Explain its principle, scope, and tools to implement it with respect to the pharmaceutical industry.