BP 702 T. INDUSTRIAL PHARMACY II (Theory)
Scope:
This course is designed to impart fundamental knowledge
on pharmaceutical product development and translation from laboratory to market
Objectives:
Upon completion of the course, the student shall be
able to:
1.
Know the process of pilot plant and scale up of pharmaceutical dosage
forms
2.
Understand the process of technology transfer from lab scale to
commercial batch
3.
Know different Laws and Acts that regulate pharmaceutical industry
4.
Understand the approval process and regulatory requirements for drug
products
Course
Content:
UNIT-I
Pilot plant scale up techniques: General considerations - including significance of personnel requirements, space requirements, raw materials, Pilot plant scale upconsiderations for Tablets, Pilot plant scale up considerations for Capsules, Pilot plant scale up considerations for liquid orals, Pilot plant scale up considerations for semi solids and relevant documentation, SUPAC guidelines, Introduction to platform technology
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
WHO guidelines for Technology Transfer (TT):
UNIT-III
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.
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
Quality Risk Management:
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.
Recommended
Books: (Latest Editions)
1. Regulatory Affairs from Wikipedia, the
free encyclopedia modified on 7th April available at http,//en.wikipedia.org/wiki/Regulatory_
Affairs.
2. International Regulatory Affairs Updates,
2005. available at http://www.iraup.com/about.php
3. Douglas J Pisano and David S. Mantus.
Text book of FDA Regulatory Affairs A Guide for Prescription Drugs, Medical
Devices, and Biologics’ Second Edition.
4. Regulatory Affairs brought by learning
plus, inc. available at http.//www.cgmp.com/ra.htm.
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