Enlist analytical method validation parameters for assay of drug products. Describe LOQ and accuracy with their evaluation techniques as per ICH.
[6 marks]What is pharmaceutical waste? Write a note on waste disposal procedures and the records to be kept for them.
[5 marks]What is the purpose of ICH guidelines? Write down the process of harmonization.
[5 marks]What is QbD? Explain elements of QbD in detail.
[6 marks]What is NABL accreditation? Discuss its importance.
[5 marks]Write objectives of GLP? Discuss in brief the key points in GLP.
[5 marks]Draw a sample plant layout for pharmaceutical industry along with space required as per schedule M.
[6 marks]Discuss maintenance of sterile area and control of contamination as a part of plant premises.
[5 marks]Why product to be recall? Write briefly about procedures to be followed for recalling a product.
[5 marks]Write a note on purchase specification and maintenance of store for raw materials.
[6 marks]Write a note on ICH stability testing guideline.
[5 marks]Write in brief about SOP.
[5 marks]Write is the difference between QA and QC. How QA, QC and GMP are correlated?
[6 marks]What is TQM? Explained various elements of TQM.
[5 marks]Write a note on Master Formula Record. Q. 6 (a) Describe the advantages and disadvantages of plastic containers with that of glass container. Discuss QC tests carried out on plastic containers.
[6 marks]Discuss general protocol for conduct of a Nonclinical laboratory study
[5 marks]Discuss BMR and its auditing with references to cGMP.
[5 marks]Write the procedure for complaints evaluation
[6 marks]Write note on disqualification of testing facilities
[5 marks]Write short note on: ISO14000
[5 marks]