Write importance and scope of validation. Discuss qualification of UV-Visible Spectrophotometer.
[6 marks]Discuss validation of analytical procedures.
[5 marks]What is pharmaceutical waste? Write a note on waste disposal procedures and the records to be kept for them.
[5 marks]Enlist different ICH guidelines. Discuss in brief about Quality guideline.
[6 marks]What is QA? Differences of QA and QC.
[5 marks]Write a detailed note on TQM.
[5 marks]Write in brief about SOP.
[6 marks]Give brief note on ISO 9000 & ISO 14000? Discuss various steps for its registration.
[5 marks]Explain importance of Quality by design. Discuss elements of QBD program.
[5 marks]Draw a sample plant layout for pharmaceutical industry along with space required as per schedule M.
[6 marks]Write a note on Master Formula Record.
[5 marks]What is a complaint? Discuss how to handle returns goods.
[5 marks]Write a brief note on GLP.
[6 marks]Discuss responsibilities of personnel in Pharmaceutical organization.
[5 marks]What does GMP cover? Write main principles of GMP for pharmaceutical products. Q. 6 (a) Write details on DQ, IQ, OQ and PQ.
[6 marks]Write the importance of training, hygiene and records of personnel in Pharmaceutical organization.
[5 marks]Define calibration. Discuss principles of calibration.
[5 marks]Discuss about maintenance of sterile areas in premises.
[6 marks]Discuss briefly good warehousing practices for different materials used in pharmaceutical industry.
[5 marks]Explain principles of NABL accreditation?
[5 marks]