To ensure that the students can understand the concept and contents, the book has been written in a clear language. Each subject has been thoroughly explained. However, certain things that are significant and valuable are covered. This will make it easier for the students to connect their theoretical learning to the real-world needs of the pharmaceutical sector.
The course would make all the students understand at least the following:
· Know the process of pilot planting and the scale of pharmaceutical dosage forms
· Understand the process of technology transfer from lab scale to commercial batch
· Know different Laws and Acts that regulate the pharmaceutical industry
· Understand the approval process and regulatory requirements for drug products
Contents:
1. Pilot Plant Scale-up Techniques
2. Technology Development and Transfer
3. Regulatory Affairs & Regulatory Requirement for Drug Approval
4. Quality Management Systems
5. Indian Regulatory Requirements
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