Your answers should be specific to the questions asked. Draw neat labeled diagrams wherever necessary.
LONG ESSAY (Answer any TWO) 2 X 20 = 40 Marks
- Explain in detail the design of the product, facilities, requirements and equipment validation for a unit dosage solid preparation.
- Explain the factors considered in production planning and inventory control measures followed in Pharmaceutical Manufacturing.
- Draw a sketch of layout for Parenteral manufacturing and explain the service facilities incorporated in it.
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SHORT ESSAY (Answer any FIVE) 5 X 10 = 50 Marks
- Explain the safety precautions followed for drugs and chemicals during manufacturing.
- Discuss ICH Guidelines for stability testing of Drugs.
- Explain how the Effluent and other wastes are managed in industry.
- Explain the Optimization methods followed in the production Department.
- Describe the service facilities provided in Pharmaceutical Units.
- Explain the Compilation procedure followed for Biological Production as per D & C Act.
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SHORT NOTES 2 X 5 = 10 Marks
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- Salient features of Intellectual property rights.
- Salient features of ISO 9001.
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