Write a note on Master Formula Record.
[6 marks]Write detailed account on TQM.
[5 marks]What is QbD? Explain different tools of QbD.
[5 marks]Discuss various quality control tests for secondary packaging materials.
[6 marks]Discuss about DQ, IQ, OQ and PQ.
[5 marks]Write a short note on NABL accreditation.
[5 marks]Write down a scope of validation. Discuss qualification of UV-Visible spectrophotometer.
[6 marks]Explain purchase specification and maintenance of store for raw material.
[5 marks]Write in detail about protocol for conduct of nonclinical laboratory study.
[5 marks]Write a short note on evaluation of complaints and handling of return good.
[6 marks]Discuss general principles of calibration and explain calibration of pH meter.
[5 marks]Explain the objectives and scope of GLP.
[5 marks]Enlist different ICH guideline and discuss guideline for stability testing.
[6 marks]Write descriptive note on SOP.
[5 marks]Discuss: Quality Audit and distribution records. Q. 6 (a) Discuss general principles of Analytical method validation.
[6 marks]Describe ISO 9000 in brief.
[5 marks]Write descriptive note on Good warehousing practice.
[5 marks]Discuss elements of QBD program.
[6 marks]Explain construction and layout of sterile manufacturing plant.
[5 marks]Discuss the regulatory requirements for design, construction and plant layout of pharmaceutical manufacturing facility.
[5 marks]