Define the terms QA, QC and GMP and explain the difference between QA and QC.
[6 marks]What is TQM? Explain the philosophies of TQM.
[5 marks]What is the purpose of ICH guidelines? Write down the process of harmonization.
[5 marks]Draw plant layout of Pharmaceutical industry and discuss the design and construction requirements for pharmaceutical manufacturing unit accorging to GMP.
[6 marks]Write down elements and registration process of ISO 9000.
[5 marks]Write a note on personal responsibilities and training.
[5 marks]What is QbD? Explain elements of QbD in detail.
[6 marks]Write a note on personnel hygiene and record.
[5 marks]Explain in detail on NABL accreditation process.
[5 marks]Write down the quality control tests for containers.
[6 marks]Explain in detail about of utilities and maintenance of sterile areas.
[5 marks]Write a note on purchase specification and maintenance of store for raw materials.
[5 marks]Define GLP. Write a note on GLP requirements for documentation in a non- clinical testing laboratory.
[6 marks]Explain disqualification of testing facility in GLP.
[5 marks]What are complaints? Write a note on evaluation of complaints. Q. 6 (a) What is SOP? Describe the contents of SOP.
[6 marks]Explain in detail quality review and quality audit.
[5 marks]Write a note on analytical method validation parameter.
[5 marks]Define calibration. Discuss the qualification of UV-Visible spectrophotometer.
[6 marks]Define validation and write down different types of validation.
[5 marks]Write a note on secondary packing material.
[5 marks]