Describe the procedure of NABL accreditation in India
[6 marks]Define QbD. What are its advantages?
[5 marks]Define Total Quality Management. Explain its elements
[5 marks]Explain the terms (i) ISO 9000 (ii) QSEM
[6 marks]Give brief account on training of personnel in pharmaceutical industry
[5 marks]Explain the plant layout for sterile facility in pharmaceutical industry
[5 marks]Enlists the factors to be considered in selection and purchase of equipments
[6 marks]Describe the maintenance of stores for raw materials
[5 marks]What do you understand by disqualification of testing facilities?
[5 marks]Explain the quality control tests performed for containers
[6 marks]Describe general protocol for conduct of a nonclinical laboratory study.
[5 marks]What are the requirements for the testing facility as per GLP?
[5 marks]What is a complaint? Give an overview on recalling the pharmaceutical product
[6 marks]Give brief account on distribution records
[5 marks]Write in brief (i) Good warehousing practice (ii) Stability testing as per ICH Q. 6 (a) What do you mean by SOP? Explain the importance of SOP in pharmaceutical industries
[6 marks]Define Quality audit. Explain the types of Quality audit
[5 marks]What is Batch Formula Record? What does it include?
[5 marks]Describe the procedure for two point Calibration of pH meter
[6 marks]Enumerate different type of validations. Explain prospective validation
[5 marks]Enlist the parameters to be checked for method validation. Explain any two
[5 marks]