Industrial Pharmacy 2 B.Pharm 7th Semester Books

Industrial Pharmacy- II Book for B.Pharmacy 7th Semester Books

Author’s Name	Dr. Sameer H Lakade Dr.IIango K B Dr. Vikas Kumar Shukla
Editions	Latest Edition
Publishers	Thakur Publication Pvt Ltd

INDUSTRIAL PHARMACY – II (SEM VII) B.PHARM

Author’s Name	USMAN SAMEER SHEIKH, GAIKWAD
Editions	Latest Edition
Publishers	S VIKAS AND COMPANY (PV)

Industrial Pharmacy-II, B.Pharmacy VII-Sem PCI

Author’s Name	Dr.Shaik Harun Rasheed
Editions	Latest Edition
Publishers	SIA Publishers & Distributors Pvt Ltd

Industrial Pharmacy 2 Topic-wise Summary

Pilot Plant Scale-up Techniques

• General Considerations
  
  • Significance of personnel requirements
    
  • Space requirements
    
  • Raw materials
    
• Pilot Plant Scale-up Considerations
  
  • Solids
    
  • Liquid orals
    
  • Semi-solids
    
• Relevant Documentation
  
• SUPAC Guidelines
  
• Introduction to Platform Technology

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
    
  • Cleaning
    
• Granularity of TT Process
  
  • API
    
  • Excipients
    
  • Finished products
    
  • Packaging materials
    
• Documentation
  
• Premises and Equipment
  
  • 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

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
    
  • Toxicology
    
• Investigational New Drug (IND) Application
  
• Investigator’s Brochure (IB)
  
• New Drug Application (NDA)
  
• Clinical Research / Bioequivalence (BE) Studies
  
• Clinical Research Protocols
  
• Biostatistics in Pharmaceutical Product Development
  
• Data Presentation for FDA Submissions
  
• Management of Clinical Studies

Quality Management Systems

• Concept of Quality
  
• Total Quality Management (TQM)
  
• Quality by Design (QbD)
  
• Six Sigma Concept
  
• Out of Specifications (OOS)
  
• Change Control
  
• Introduction to Quality System Standards
  
  • ISO 9000 series
    
  • ISO 14000
    
  • NABL
    
  • GLP

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