Enlist analytical method validation parameters for assay of drug products. Describe LOQ and accuracy with their evaluation techniques as per ICH.
[6 marks]Discuss validation of UV – Visible spectrophotometer.
[5 marks]What is pharmaceutical waste? Write a note on waste disposal procedures and the records to be kept for them.
[5 marks]What are the tools of QbD? Discuss briefly.
[6 marks]Differentiate: Batch Formula Record and Master Formula Record.
[5 marks]Write in brief about handling of returned goods with suitable examples.
[5 marks]Describe the advantages and disadvantages of plastic containers with that of glass container. Discuss QC tests carried out on plastic containers.
[6 marks]Write objectives of GLP? Discuss in brief the key points in GLP.
[5 marks]What is ISO? Write benefits of ISO. Describe steps for registration in general.
[5 marks]What is QA? Describe concepts and differences of QA and QC in brief.
[6 marks]Write a brief note on TQM.
[5 marks]Why product to be recall? Write briefly about procedures to be followed for recalling a product.
[5 marks]Write benefits of laboratory accreditation. Explain principles of NABL accreditation?
[6 marks]Explain the term: Storage. Discuss briefly good warehousing practices for different materials used in pharmaceutical industry.
[5 marks]Write a note on purchase specifications for equipment. Q. 6 (a) Discuss about maintenance of sterile areas in premises.
[6 marks]Write a note on ICH stability testing guideline.
[5 marks]What is ICH? Give brief overview of QSEM code assigned to ICH guideline. Enlist categories in which process of harmonization implemented by ICH.
[5 marks]What is QbD? Discuss QTPP and CQA.
[6 marks]Write in brief about SOP.
[5 marks]Discuss about responsibilities and training guideline for personnel in an organisation.
[5 marks]