INDUSTRIAL PHARMACY - II

 BP 702 T. INDUSTRIAL PHARMACY - II

 Syllabus:


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Unit I: Pilot Plant Scale-Up Techniques (10 Hours)

1. General Considerations

• Significance of Personnel Requirements
• Space Requirements
• Raw Materials

2. Pilot Plant Scale-Up Considerations

• Solids
• Liquid Orals
• Semi-Solids
• Relevant Documentation

3. SUPAC Guidelines

• Introduction to SUPAC (Scale-Up and Post-Approval Changes)
• Application in Different Pharmaceutical Forms

4. Introduction to Platform Technology

Unit II: Technology Development and Transfer (10 Hours)

1. Technology Transfer: Basics and Guidelines

• WHO Guidelines for Technology Transfer (TT)
• Terminology
• Technology Transfer Protocol
• Quality Risk Management

2. R&D to Production Transfer

• Process, Packaging, and Cleaning Considerations
• Granularity of TT Process (API, Excipients, Finished Products, Packaging Materials)
• Documentation Requirements

3. Premises, Equipment, and Quality Control

• Premises and Equipment Qualification and Validation
• Analytical Method Transfer
• Approved Regulatory Bodies and Agencies

4. Commercialization: Practical Aspects and Challenges

• Case Studies
• TT Agencies in India: APCTD, NRDC, TIFAC, BCIL, TBSE/SIDBI
• TT-Related Documentation: Confidentiality Agreements, Licensing, MoUs, Legal Issues

Unit III: Regulatory Affairs (10 Hours)

1. Introduction to Regulatory Affairs

• Historical Overview
• Regulatory Authorities
• Role of Regulatory Affairs Department
• Responsibilities of Regulatory Affairs Professionals

2. Regulatory Requirements for Drug Approval

• Drug Development Teams
• Non-Clinical Drug Development: Pharmacology, Metabolism, Toxicology
• IND Application, Investigator’s Brochure, NDA
• Clinical Research and Bioequivalence Studies

3. Biostatistics and Data Presentation

• Role in Pharmaceutical Product Development
• Data Presentation for FDA Submissions
• Management of Clinical Studies

Unit IV: Quality Management Systems (08 Hours)

1. Quality Management and Certifications

• Concept of Quality
• Total Quality Management
• Quality by Design (QbD)
• Six Sigma Concept
• Out of Specifications (OOS) Management

2. Quality Standards

• ISO 9000 Series of Quality Systems Standards
• ISO 14000 and Environmental Standards
• NABL (National Accreditation Board for Testing and Calibration Laboratories)
• GLP (Good Laboratory Practice)

Unit V: Indian Regulatory Requirements (07 Hours)

1. Regulatory Authorities in India

• CDSCO (Central Drug Standard Control Organization) and State Licensing Authority
• Organization Structure and Responsibilities

2. Regulatory Procedures and Approvals

• Certificate of Pharmaceutical Product (COPP)
• Regulatory Requirements for New Drugs

Note: The rearranged syllabus organizes the topics in a logical sequence, grouping related topics together under each unit.