Write principles and procedures NABL accreditation
[6 marks]Write difference between Q.Aand Q.C
[5 marks]Write short note on TQM
[5 marks]Write design, construction and plant layout of pharmaceutical industry.
[6 marks]Write note on utilities and maintenance of sterile areas
[5 marks]Write note on maintenance of stores for raw materials.
[5 marks]Write note on protocol for conduct of a nonclinical laboratory study
[6 marks]Write various quality control test for containers and rubber closures
[5 marks]Write note on disqualification of testing facilities
[5 marks]Write note on master formula record
[6 marks]Write note on SOP
[5 marks]Write the procedure for complaints evaluation
[5 marks]What is process validation? Explain prospective and retrospective validation
[6 marks]Discuss DQ and IQ in process validation.
[5 marks]Explain revalidation criteria. Q. 6 (a) What is validation master plan? Explain its importance in Setting up of new manufacturing facility
[6 marks]Discuss analytical method validation according to ICH Guidelines
[5 marks]Write note on Quality audit
[5 marks]Write a note on qualification of UV-Visible spectrophotometer
[6 marks]Write note on good warehousing practice
[5 marks]Write short note on: ISO14000
[5 marks]