Write is the difference between QA and QC. How QA, QC and GMP are correlated?
[6 marks]Enlist different ICH guidelines. Discuss in brief about Quality guideline.
[5 marks]What is QbD? Discuss different tools of QbD.
[5 marks]Draw a sample plant layout for pharmaceutical industry along with space required as per schedule M.
[6 marks]Discuss maintenance of sterile area and control of contamination as a part of plant premises.
[5 marks]Discuss various quality control tests for secondary packaging materials.
[5 marks]Give brief note on ISO 9000 & ISO 14000? Discuss various steps for its registration.
[6 marks]Discuss principles of GLP.
[5 marks]What is TQM? Explained various elements of TQM.
[5 marks]Give brief note on Quality control test for containers and rubber closures.
[6 marks]What is difference between calibration, validation and qualification? Discuss any two validation parameters in detail.
[5 marks]Discuss various characteristics to be validated for different types of analytical procedures.
[5 marks]What is a complaint? Discuss how to handle returns goods.
[6 marks]Discuss BMR and its auditing with references to cGMP.
[5 marks]Write a note on Master Formula Record. Q. 6 (a) Define calibration. Discuss principles of calibration.
[6 marks]Discuss general protocol for conduct of a Nonclinical laboratory study.
[5 marks]Write brief note on SOP.
[5 marks]Discuss about personnel responsibility and hygiene in pharmaceutical industry.
[6 marks]What is NABL accreditation? Discuss its importance.
[6 marks]Write short note on Qualification of UV-Visible spectrophotometer.
[6 marks]