B Pharm Industrial Pharmacy 2 Unit 2 PDF Notes
B-Pharmers, get ready to witness the magic behind bringing new drugs to life in B Pharm Industrial Pharmacy 2 Unit 2 PDF Notes! We'll delve into technology transfer (TT), the intricate process of moving innovative medicines from research labs to large-scale production. Imagine translating brilliant ideas into real-world medications, ensuring every step adheres to strict guidelines like the WHO's TT protocols. Buckle up as we explore quality risk management, identifying and mitigating potential issues throughout the transfer. We'll follow the journey from R&D to production, ensuring processes, packaging, and cleaning are meticulously transferred. Think beyond the final product; we'll explore transferring knowledge for APIs, excipients, packaging, and more! Documentation, equipment qualification, and analytical method transfer are crucial, and we'll cover them all. By the end, you'll understand the complexities and importance of TT, preparing you to contribute to the exciting world of bringing new medicines to patients. Remember, it's not just science; it's about making a global impact on healthcare!
B Pharm Industrial Pharmacy 2 Unit 2 PDF Notes
Unit 2
Technology development and transfer: WHO guidelines for Technology Transfer(TT): Terminology, Technology transfer protocol, Quality risk management, Transfer from R & D to production (Process, packaging and cleaning), Granularity of TT Process (API, excipients, finished products, packaging materials) Documentation, Premises and equipments, qualification and validation, quality control, analytical method transfer, Approved regulatory bodies and agencies, Commercialization - practical aspects and problems (case studies), TT agencies in India - APCTD, NRDC, TIFAC, BCIL, TBSE / SIDBI; TT related documentation - confidentiality agreement, licensing, MoUs, legal issues
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