Industrial Pharmacy II Notes [U-2]
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Technology Development and Transfer in Industrial Pharmacy Notes
- Introduction: Technology Development and Transfer in Industrial Pharmacy
- WHO guidelines for Technology Transfer(TT)
- Terminology of Technology Transfer (TT)
- Technology Transfer Protocol
- Quality risk management of TT
- Transfer from R&D to Production (Process, Packaging, and Cleaning)
- Granularity of TT Process (API, Excipients, Finished Products, Packaging Materials)
- Documentation in Technology Transfer (TT)
- Premises and Equipment in Technology Transfer
- Qualification and Validation in Technology Transfer for Industrial Pharmacy
- Quality Control (QC) in Technology Transfer (TT)
- Analytical Method Transfer (AMT) in Technology Transfer (TT)
- Approved Regulatory Bodies and Agencies
- Commercialization – Practical Aspects and Problems (Case Studies)
- Technology Transfer Agencies in India – APCTD, NRDC, TIFAC, BCIL, TBSE/SIDBI
- Technology Transfer Related Documentation
