Good Manufacturing Practices detail syllabus for various departments, 2017 scheme is taken from VTU official website and presented for VTU students. The course code (17BT663), and for exam duration, Teaching Hr/week, Practical Hr/week, Total Marks, internal marks, theory marks, duration and credits do visit complete sem subjects post given below.
For all other open elective-2 syllabus for vtu be 2017 scheme you can visit Open Elective-2 syllabus for VTU BE 2017 Scheme Subjects. The detail syllabus for good manufacturing practices is as follows.
Course Objectives:
This course will enable students to understand the aspects of good manufacturing practices from its regulatory and application perspective.
Module 1
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Module 2
CONCEPTS OF QUALIFICATION AND VALIDATION: Concepts of equipment qualification – Concepts of Validation and importance of the same -Method & Process development and validation – Validation Master Plan (VMP).
Module 3
GOOD DOCUMENTATION PRACTICES: Importance and need for GDP – Standard Operating Procedures (SOP) and Standard Testing Procedures (STP) – Raw Data Sheet (RDS) to Reports – Batch Manufacturing Record – Electronic records regulation – 21 CFR Part 11
Module 4
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Module 5
ADVANCES IN GMP: Parametric release of products – Quality Risk Management System – Process Analytical Technologies – Quality by Design.
Course Outcomes:
After studying this course, students will be able to:
- Learn and adopt quickly in a GMP environment.
- Understand the principles and applications of the GMP.
Reference Books:
- U.S. Department of Health and Human Services Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, 2016.
- U.S. Department of Health and Human Services Sterile Drug Products Produced by Aseptic Processing Current Good Manufacturing Practice 2004
Text Books:
- Syed Imtiaz Haider., Pharmaceutical Master Validation Plan The Ultimate Guide to FDA, GMP, and GLP Compliance, ST. LUCIE PRESS 2002.
- WHO Good manufacturing practices and inspection 2004.
- John Sharp ., Good Pharmaceutical Manufacturing Practice Rationale and Compliance 2005
For detail syllabus of all other subjects of BE do syllabus for different schemes from menu given on top.
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