What is QbD? Explain elements of QbD in detail.
[6 marks]Write a note on Master Formula Record.
[5 marks]Write in detail about protocol for conduct of nonclinical laboratory study.
[5 marks]Write a note on purchase specification and maintenance of store for raw materials.
[6 marks]Discuss various quality control tests for secondary packaging materials.
[5 marks]Write principles and procedures of NABL accreditation.
[5 marks]Write design, construction and plant layout of Pharmaceutical Industry.
[6 marks]What is TQM? Explain the philosophies of TQM.
[5 marks]Enlist different ICH guidelines. Discuss in brief about Quality guideline.
[5 marks]Discuss in brief : ISO 9000 and ISO 14000. Discuss various steps for its registration.
[6 marks]Write a brief note on GLP.
[5 marks]Write the importance of training, hygiene and records of personnel in Pharmaceutical organization.
[5 marks]Write various quality control test for glass and plastic containers.
[6 marks]What is complaint? Explain its types and procedure for handling the complaint.
[5 marks]Discuss about maintenance of sterile areas in premises.
[5 marks]Write a detailed note on SOP.
[6 marks]Discuss responsibilities of personnel in Pharmaceutical organization.
[5 marks]Write note on good warehousing practice.
[5 marks]Define calibration. Discuss the qualification of UV-Visible spectrophotometer.
[6 marks]Write a note on analytical method validation parameters.
[5 marks]Discuss: Quality Audit and Distribution records. Page 1 of 1
[5 marks]