7th Semester - Industrial Pharmacy II
B Pharm 7th Semester Notes Validity
FirstHope B Pharm 7th semester Notes are ideal for university & competitive exams like GPAT & NIPER. These notes are designed according to PCI guidelines valid & sufficient for AKTU University, RTU University, Jamia Hamdard-Delhi University, Anna University, Savitribai Phule University, Shivaji University, NTR University, Andhra University, and other state and private universities across India.
These Notes are Much better & reliable then carewell pharma notes or imperfect pharmacy notes.
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Industrial Pharmacy II Notes – BPharma 7thSemester notes
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General Considerations – Personnel, space, raw materials & documentation
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Scale-Up Techniques for Dosage Forms – Solids, liquids, semi-solids
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SUPAC Guidelines – Scale-up & post-approval changes
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Introduction to Platform Technology
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WHO Guidelines for Technology Transfer (TT) – Process, packaging, and cleaning
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Granularity of TT Process – API, excipients, finished products, packaging materials
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TT Documentation – Confidentiality agreement, licensing, MoUs, legal issues
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TT Agencies in India – APCTD, NRDC, TIFAC, BCIL, TBSE, SIDBI
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Commercialization Challenges & Case Studies
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Regulatory Affairs Overview – Historical perspective, role & responsibilities
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Regulatory Requirements for Drug Approval – IND, NDA, Investigator’s Brochure (IB)
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Clinical Research & Biostatistics in Drug Development
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FDA Submissions & Clinical Study Management
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Concept of Quality in Pharmaceuticals – Total Quality Management (TQM), Quality by Design (QbD), Six Sigma
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Out of Specifications (OOS) & Change Control
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Quality Certifications – ISO 9000, ISO 14000, NABL, GLP
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Central Drugs Standard Control Organization (CDSCO) & State Licensing Authority
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Roles & Responsibilities of CDSCO
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Certificate of Pharmaceutical Product (COPP)
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New Drug Approval Process in India
✨ Why Choose These Notes?
✅ Short, Exam-Oriented & Well-Organized – Perfect for semester & competitive exams
✅ Valid for AKTU, RTU, Delhi University, Anna University, Savitribai Phule University, Shivaji University, NTR University, Andhra University & More
✅ Covers Theory, Formulas & Practical Applications for quick understanding
✅ Highly useful for GPAT, NIPER & Other Competitive Exams
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