Regulatory Affairs in Biotech Industry detailed Syllabus for Biotechnology Engineering (BIOTECH), 2018 scheme has been taken from the VTUs official website and presented for the VTU students. For Course Code, Subject Names, Teaching Department, Paper Setting Board, Theory Lectures, Tutorial, Practical/Drawing, Duration in Hours, CIE Marks, Total Marks, Credits and other information do visit full semester subjects post given below. The Syllabus PDF files can also be downloaded from the official website of the university.
For all other VTU BIOTECH 8th Sem Syllabus for BE 2018 Scheme, do visit VTU BIOTECH 8th Sem Syllabus for BE 2018 Scheme Subjects. The detailed Syllabus for regulatory affairs in biotech industry is as follows.
Course Objectives:
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Module 1
INTRODUCTION: Validation and Regulatory Affairs in Bio (Pharmaceutical) Manufacturing: An Introduction to FDA Operations & Industry Compliance Regulations, The Fundamentals of Regulatory Compliance with respect to Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) & Good Laboratory Practice (GLP). An Introduction to the Basic Concepts of Process Validation & how it Differs from Qualification (IQ, OQ & PQ) Procedures, A Review of Prospective, Concurrent, Retrospective Validation & Revalidation. ISO 9000 Series & International Harmonization & their effect upon GMP’s.
Module 2
VALIDATION: Validation of Water & Thermal Systems, including HVAC Facilities & Cleaning Validation. Validation of Active Pharmaceutical Ingredients (APIs) & Aseptic Processes. Validation of Non-Sterile Processes (used in the manufacture of Solids, Liquids, & Semisolid Dosage Forms). Overview of method evolution, FDA and ICH guidelines, Development and validation, Basic statistical concepts, Outliers, Specificity: sample preparation, Specificity: separations, Specificity: detectors, Linearity, Accuracy, Precision, Limits of detection (LOD) and quantification (LOQ), Minimum detectable amount (MDA), Sample stability and method robustness, Window diagrams, System suitability, Statistical process control for HPLC, Sustainable validation, Troubleshooting out-of control systems, case studies.
Module 3
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Module 4
QUALITY AND IMPLEMENTATION: Terminology Relating to Quality, Quality Requirement, Customer Satisfaction, Capability; Terms Relating to Management, Management System, Quality Management System, Quality Policy, Quality Objectives, Quality Planning, Quality Control, Quality Assurance, Quality Improvement, Continual Improvement, Effectiveness, Efficiency, Terms relating to Characteristics, Quality Characteristics; Terms Relating to Conformity, NonConformity, Defect, Preventive Action, Corrective Action, Correction, Rework, Repair, Scrap, Concession, Deviation Permit, Release; Objective Evidence, Inspection, Test, Metrological Confirmation. Final Inspection and Testing,
Module 5
QUALITY MANAGEMENT: The development of regulatory requirements for validation, The V model and Life Cycle model approach to validation and documentation, Risk Analysis Techniques: Impact Assessment; Failure Mode and Effects Analysis (FMEA), Validation Master Plans, Contamination Control, Risk Management in the Pharmaceutical Industry, Solid Dose Manufacture Principles and Practices, Liquid and Cream Manufacture Principles and Practices, Good Laboratory Practices (for Non-Clinical Laboratories), Computer Systems Validation Principles and Practices, Good Aseptic Practices and Sterile Products, Clinical Trials Quality Assurance Management, Pharmaceutical Engineering-Facility, Equipment and Process Design, Fundamentals of Process Analytical Technology, Quality and Continuous Improvement in the Biotech Industry.
Course Outcomes:
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Question paper pattern:
- The question paper will have ten full questions carrying equal marks.
- Each full question will be for 20 marks.
- There will be two full questions (with a maximum of four sub- questions) from each module.
- Each full question will have sub- question covering all the topics under a module.
- The students will have to answer five full questions, selecting one full question from each module.
Text Books:
- Pharmaceutical Process Validation Robert Nash and Alfred Wachter, Marcel Dekker New York : Marcel Dekker, 2003.
- Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control from Manufacturer to Consumer Sidney J. Willig, Marcel Dekker New York : Marcel Dekker, 2001
- Validation of Pharmaceutical Processes: Sterile Products Frederick J. Carlton and James Agalloco New York : Marcel Dekker, 3rd Edition 2008
- Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries Syed ImtiazHaider Saint Lucie Press 2001
Reference Books:
For the complete Syllabus, results, class timetable, and many other features kindly download the iStudy App
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For detail Syllabus of all other subjects of BE 8th Sem Biotechnology Engineering, visit (BIOTECH) 8th Sem Syllabus Subjects.
For all (CBSE & Non-CBSC) BE results, visit VTU BE all semester results direct links.