Regulatory Affairs in Biotech Industry detail syllabus for Biotechnology (Bt), 2017 scheme is taken from VTU official website and presented for VTU students. The course code (17BT82), 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 bt 8th sem syllabus for be 2017 scheme vtu you can visit BT 8th Sem syllabus for BE 2017 Scheme VTU Subjects. The detail syllabus for regulatory affairs in biotech industry is as follows.
Course Objectives:
The objective of this course is to educate students about regulatory rules and guidelines that specify parameters of the safety and quality standards in the biotech industry
Module 1
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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
STANDARDS: Introduction, ISO 9000 Series of Standards, Management Responsibility, Quality System, Contract Review, Design Control, Document and Data Control, Preservation and Delivery, Control of Quality Records, Internal Quality Audits, Training, Servicing, Statistical Techniques, ISO-9001-2000, Scope, Normative Reference, Terms and Definitions, Quality Management, System, Documents Requirements, Management’s Responsibility, Resource Management, Infrastructure, Product Realization, Measurement, Analysis and Improvement, ISO-14001, Environmental Management Systems.
Module 4
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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, Commissioning and Qualification, Process Validation, Routine validation and revalidation, 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, GxP and Quality Auditing Practices, Pharmaceutical Engineering – Facility, Equipment and Process Design, Fundamentals of Process Analytical Technology, Quality and Continuous Improvement in the Biotech Industry.
Course Outcomes:
After studying this course, students will be able to:
- Outline the importance of the quality and compliance in the biotech industry
- Comprehend the various regulatory guidelines and rules as well as the organizations governing the same.
Reference Books:
- Pharmaceutical Equipment Validation: The Ultimate Qualification Handbook, Phillip A. Cloud, Interpharm Press.
- Commissioning and Qualification, ISPE Pharmaceutical Engineering Baseline Guides Series.
- ICH guideline Q6B, Freelance Publishing
Text Books:
- Pharmaceutical Process Validation by Robert Nash and Alfred Wachter, Marcel Dekker.
- Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control from Manufacturer to Consumer, Sidney J. Willig, Marcel Dekker.
- Validation of Pharmaceutical Processes: Sterile Products, Frederick J. Carlton (Ed.) and James Agalloco (Ed.), Marcel Dekker.
- Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries, Syed Imtiaz Haider, Saint Lucie Press.
- Pharmaceutical Biotechnology by S P Vyas and V K Dixit, CBS Publishers
For detail syllabus of all other subjects of BE Bt, 2017 scheme do visit Biotech 8th Sem syllabus for 2017 scheme.
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