Define & explain the concept of QA, QC and GMP.
[6 marks]Write detailed account on TQM.
[5 marks]Describe ISO 9000 in brief.
[5 marks]Discuss briefly the overview of QSEM guidelines of ICH. Discuss specially Q- series guidelines.
[6 marks]Explain importance of Quality by design. Discuss elements of QBD program.
[5 marks]Discuss principles and procedures for NABL accreditation.
[5 marks]Discuss responsibilities of personnel in Pharmaceutical organization.
[6 marks]Write the importance of training, hygiene and records of personnel in Pharmaceutical organization.
[5 marks]Explain design, construction and plant layout of sterile manufacturing plant.
[5 marks]Write detailed account on quality control test for containers of various dosage forms.
[6 marks]Write a short note on Batch Formula Record & Master Formula Record.
[5 marks]Discuss selection and purchase specifications of equipments.
[5 marks]Discuss evaluation of complaints and Handling of return goods.
[6 marks]Write descriptive note on SOP.
[5 marks]Discuss: Quality Audit, Quality Review and Quality documentation. Q. 6 (a) Write importance and scope of validation. Discuss qualification of UV-Visible Spectrophotometer.
[6 marks]Discuss general principles of Analytical method validation.
[5 marks]Write details on DQ, IQ, OQ and PQ.
[5 marks]Write brief account on GLP.
[6 marks]Discuss protocols, Records and Reports for Conduct of a Nonclinical Laboratory study.
[5 marks]Write note on Good warehousing practice and material management.
[5 marks]