Draw neat, labeled diagrams wherever necessary.
FirstRanker.com 3 x 15 = 45 Marks
- Write in detail about USGMP.
- Write in detail about USFDA GLP regulations.
- Write in detail about principles and requirements of GALP.
- Write in detail principles and legal GDP requirements.
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SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
- Write briefly about WHO cGMP guidelines.
- Write briefly about training documentation of GALP.
- Write briefly about the concept of ISO.
- Write a note on software evaluation checklist.
- Write a note on stability testing principles.
- Write a note on Total Quality Management.
- Write briefly about cleaning validation.
- Write briefly about cGMP guidelines related to medical devices.
- Describe the goals of laboratory quality audit.
- Write a note on validation master plan.
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