7th Semester, Industrial Pharmacy- 2, all units PDF
UNIT-I
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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UNIT-II
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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UNIT-III
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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UNIT-IV
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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UNIT-V
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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👉first Order Reaction, Order Of Reaction, Chemical Kinetics :- click here
👉Solid state decomposition, Order of Reaction, Chemical Kinetics :- click here
👉What is Half Life and Shelf Life, Order of Reaction, Chemical Kinetics :- click here
👉Apparent Zero Order Suspension, Chemical Kinetics, Physical Pharmaceutics :- click here
👉Zero Order Reaction, Chemical kinetics :- click here
