B.Pharmacy 7th Semester Industrial Pharmacy 2 Notes & Important Question Answer
B.Pharma VIIth Semester Industrial Pharmacy 2 Important Topics With All The Important Question And Answer Are Publish Here Download the Pdf and Give boost To Your Preparation. Stay Connected with us for your future examination all the important content will publish here . Your Full Pharmacy Syllabus will Be published here.
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| B.Pharmacy 7th Semester Industrial Pharmacy 2 Notes |
Industrial Pharmacy 2 - Unit 1
- Pilot plant scale up techniques: General considerations - including significance of personnel requirements, space requirements, raw materials, Pilot plant scale up considerations for solids, liquid orals, semi solids and relevant documentation, SUPAC guidelines, Introduction to platform technology
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B.pharma 7th Sem Industrial Pharmacy 2 Unit 1 Important Topics PDF:- Click Here
Industrial Pharmacy 2 - 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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B.pharma 7th Sem Industrial Pharmacy 2 Unit 2 Important Topics PDF:- Click Here
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Industrial Pharmacy 2 - Unit 3
- Regulatory affairs: Introduction, Historical overview of Regulatory Affairs, Regulatory authorities, Role of Regulatory affairs department, Responsibility of Regulatory Affairs Professionals
- Regulatory requirements for drug approval: Drug Development Teams, Non-Clinical Drug Development, Pharmacology, Drug Metabolism and Toxicology, General considerations of Investigational New Drug (IND) Application, Investigator’s Brochure (IB) and New Drug Application (NDA), Clinical research / BE studies, Clinical Research Protocols, Biostatistics in Pharmaceutical Product Development, Data Presentation for FDA Submissions, Management of Clinical Studies.
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B.pharma 7th Sem Industrial Pharmacy 2 Unit 3 Important Topics PDF:- Click Here
Industrial Pharmacy 2 - Unit 4
- Quality management systems: Quality management & Certifications: Concept of Quality, Total Quality Management, Quality by Design (QbD), Six Sigma concept, Out of Specifications (OOS), Change control, Introduction to ISO 9000 series of quality systems standards, ISO 14000, NABL, GLP
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B.pharma 7th Sem Industrial Pharmacy 2 Unit 4 Important Topics PDF:- Click Here
Industrial Pharmacy 2 - Unit 5
- Indian Regulatory Requirements: Central Drug Standard Control Organization (CDSCO) and State Licensing Authority: Organization, Responsibilities, Certificate of Pharmaceutical Product (COPP), Regulatory requirements and approval procedures for New Drugs.
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B.pharma 7th Sem Industrial Pharmacy 2 Unit 5 Important Topics PDF:- Click Here
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Industrial Pharmacy 2 book PDF Downloading Link
- Industrial Pharmacy 2 Nirali Publication Full Book PDF:- Click Here
- Industrial Pharmacy 2 PV Publication Full Book PDF:- Click Here
- Industrial Pharmacy 2 Thakur Publication Full Book PDF:- Click Here
B Pharmacy 7th Semester Notes
B.Pharmacy 7th Semester All Subject Notes:- Click Here
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