Drug Delivery, Biotechnology, Validation Requirements and Regulatory Affairs
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Drug Delivery, Biotechnology, Validation Requirements and Regulatory Affairs Syllabus — Unit-wise Content
The official GTU curriculum for Drug Delivery, Biotechnology, Validation Requirements and Regulatory Affairs (subject code 3173621) as prescribed for Chem. Tech. · Semester 7 divides the course into 5 units, covering 19 listed topics. The unit-wise breakdown below is read from the GTU syllabus document for this subject code, so you can check what the course actually covers before deciding which papers to attempt.
Download the official syllabus PDF (3173621)Unit 1 Drug delivery system
- Large scale manufacture and packing with focus on equipment with reference to Oral sustained and controlled release dosage forms
- Introduction to Novel drug Delivery Systems Transdermal
- Transmucosal (buccal
- Ophthalmic Colloidal: Liposome’s
- emulsion systems
Unit 3 Application of Biotechnology in foods, pharma
- Application of Biotechnology in foods
- pharma, and other industries with specific reference to enzymes
- Principles of surface and solid state fermentation
- Design of different fermentors and the biochemical engineering aspects
- Process control of fermentation
- Fermentation technology of industrial chemicals
- organic acids
- amino acids
- antibiotics, etc
Unit 4 Enzyme fermentation and technology including immobilization and enzyme
- Genetic engineering principles & techniques and its application in medicines
- cloning and other fields
Unit 5 Validation and Regulatory Requirements, cGMP and Quality assurance, Schedule M,
- Process& product validation and quality audits
Unit 6 New drug application (NDA), generic products(ANDA), Schedule Y, DPCO, drugs
- and cosmetics act and rules including licensing intermediates industry
- ICH guidelines. 8 Subject Code: 3173621 w.e.f
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