Industrial Pharmacy-II

Course Objectives

To impart fundamental knowledge on pharmaceutical product development and translation from laboratory to market

Course Outcomes

CO	Statement	Mapping with POs
CO-1	To understand various Pharmaceutical Dosage forms and their manufacturing techniques	PO1, PO2, PO10
CO-2	To Know various considerations in development of pharmaceutical dosage forms	PO1, PO2, PO10, PO11
CO-3	To formulate and evaluate solid, liquid and semisolid dosage forms	PO1, PO2, PO10
CO-4	To correlate the theoretical knowledge with professional and practical need of Pharmaceutical industry.	PO1, PO2, PO6 PO10
CO-5	Able to Select the appropriate packaging materials for various pharmaceutical dosages form.	PO1, PO2, PO10

Course Syllabus

Module 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.

Module 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.

Module III:

Regulatory affairs: Introduction, Historical overview of Regulatory Affairs, Regulatory authorities, Role of Regulatory affairs department, Responsibility of Regulatory Affairs Professionals.

Module IV:

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 V:

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 VI:

Indian Regulatory Requirements: Central Drug Standard control Organizaion (CDSCO), State Lisencing Authority: Organization, Responsibilities, Certificate of Pharmaceutical Product (COPP), Regulatory requirements and approval procedures for new drugs.

Session Plan

Session 1

Pilot plant scale up techniques: Introduction

1. INTRODUCTION

1. Pilot Plant scale up

1. process scale up

Session 2

General considerations - including significance of personnel requirements, space requirements, raw materials

2. General Considerations During Pilot Plant Scale

Session 3

Pilot plant scale up considerations for solids

3. Pilot Plant scale up for solids

Session 4

Pilot plant scale up considerations for liquid orals

4. process scale up for liquids and semisolids

Session 5

Pilot plant scale up considerations for semi solids

5. ProcessScale-Up for liquids and semisolids

Session 6

SUPAC guidelines

6. SUPAC in scale up

Session 7

Introduction to platform technology

7. Platform Technology

Session 8

Technology development and transfer

8. TT- Introduction

8. Technology-transfer

Session 9

WHO guidelines for Technology Transfer(TT)

9. TOT_WHO

Session 10

Terminology, Technology transfer protocol

10. TT- Protocol

Session 11

Quality risk management

11. The Risk Management of Tech Transfer

Session 12

Transfer from R & D to production (Process, packaging and cleaning)

12. R & D to production

Session 13

Granularity of TT Process (API, excipients, finished products, packaging materials), Documentation, Premises and equipments, qualification and validation, quality control

13. Granularity of TT Process (API, excipients, finished products, packaging materials)