Industrial Pharmacy II Free Notes Download – B. Pharm

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

Download Notes

Download Handwritten Notes

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

Download Notes

Download Standard Notes

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.

Download Notes

Download Standard Notes

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

Download Notes

Download Standard Notes

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.

Download Notes

Download Standard Notes

Download Standard Notes