Validation in Pharmaceutical Industries detailed syllabus for Pharmacy (Pharma) for 2021 regulation curriculum has been taken from the Anna Universities official website and presented for the Pharma students. For course code, course name, number of credits for a course and other scheme related information, do visit full semester subjects post given below.
For Pharmacy 5th Sem scheme and its subjects, do visit Pharma 5th Sem 2021 regulation scheme. For Professional Elective-III scheme and its subjects refer to Pharma Professional Elective-III syllabus scheme. The detailed syllabus of validation in pharmaceutical industries is as follows.
Course Objectives:
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Unit I
CONCEPTS OF VALIDATION 9
Introduction – Regulatory basis for process validation – Total approach to pharmaceutical process validation – Pilot- scale up and process validation – Process validation order of priority – Process characterization and optimization techniques – Process validation as a quality assurance tool.
Unit II
EQUIPMENT VALIDATION 9
Introduction – Project Scope- Prequalification – Installation Qualification –Operation Qualification – Process qualification – Equipment Approval – change Control.
Unit III
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Unit IV
ANALYTICAL METHOD VALIDATION 9
Introduction –Premarketing activities in assay validation methods development- Validation on analytical procedures(Q2A) – Validation for a NDA, ANDA – Validation in the quality control laboratory and transfer of methods from one laboratory to another.
Unit V
PROCESS VALIDATION 9
Process validation as a quality assurance tool-General QA tools, purpose of process validation, Qualification activities, Process validation activities. Prospective process validation-Organization, documentation, product development, development of manufacturing capability, full scale production development, defining experimental programs, experimental design and analysis.
Course Outcomes:
- Understand about the validation approach in pharmaceutical industries.
- Perform the different equipment validation process for successful installation of equipment.
- Design and develop process in cleaning the equipment based on cleaning validation in pharmaceutical industries.
- Design, develop an experiment process using modern equipment tools in identifying the drug substances and products.
- Demonstrate the different process and activities involved in the new product development.
- Understand the various process and procedure to ensure the quality of the pharmaceutical product.
Text Books:
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Reference Books:
- Michael Levin, Pharmaceutical Process Scale-Up, Drugs and Pharm. Sci. Series, Vol. 157,2nd Ed., Marcel Dekker Inc., N.Y.
- Pharmaceutical Equipment Validation: The Ultimate Qualification Handbook, Phillip A. Cloud, Interpharm Press
- Analytical Method validation and Instrument Performance Verification by Churg Chan, Heiman Lam, Y.C. Lee, Yue. Zhang, Wiley Inter Science.
For detailed syllabus of all the other subjects of Pharmacy 5th Sem, visit Pharma 5th Sem subject syllabuses for 2021 regulation.
For all Pharmacy results, visit Anna University Pharma all semester results direct link.