Industrial Pharmacy- II Book B.Pharm 7th Semester

Syllabus

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.

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), Granularit y of TT Process (API, excipients, finished products, packaging materials) Documentation, Premises and equipment’s, 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.

 Module 03                                                                                       

Regulatory Affairs

·    Introduction, Historical overview of Regulatory Affairs, Regulator y 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.

 Module 04                                                                                                                      

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.

 Module 05                                                                                                                       

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.

Syllabus

Module 01                                                                                                                            10Hours

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.

Module 02                                                                                                                           10 Hours

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), Granularit y of TT Process (API, excipients, finished products, packaging materials) Documentation, Premises and equipment’s, 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.

Module 03                                                                                                                           10 Hours

Regulatory Affairs

·    Introduction, Historical overview of Regulatory Affairs, Regulator y 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.

Module 04                                                                                                                           08 Hours

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.

Module 05                                                                                                                           07 Hours

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.