Quality Control and Regulatory affairs detail syllabus for Biotechnology (Biotechnology), 2021-22 scheme is taken from AKTUs official website and presented for the AKTU B.Tech students. For the course code (KBT076), exam duration, teaching hr/week, practical hr/week, total marks, internal marks, theory marks, duration, credits, and other details do visit complete semester subjects post given below.
For the Biotechnology 7th Sem Syllabus for AKTU B.Tech 2021-22 Scheme you can visit Biotechnology 7th Sem 2021-22 Scheme. For the Departmental Elective-5 scheme of Biotechnology 7th Sem 2021-22 regulation do refer to Departmental Elective-5 Biotechnology 7th Sem scheme. The detail syllabus for quality control and regulatory affairs is as follows.
PreRequisites:
For the complete syllabus, results, class timetable, and many other features kindly download the iStudy App
It is a lightweight, easy to use, no images, and no pdfs platform to make students’s lives easier.
Course Objectives:
- This course is designed with an objective to provide an understanding of the knowledge of Quality control and Quality management
- To learn the concepts of GMP,GLP, standard test procedure and CPCSEA guidelines in Biological samples
- To provide the knowledge of Quality review and batch release document, audits of quality control etc.
- To develop understanding of Good documentation processes, clinical studies guidelines, IP generation pharmacovigilance and product registration guidelines etc.
Course Outcomes:
For the complete syllabus, results, class timetable, and many other features kindly download the iStudy App
It is a lightweight, easy to use, no images, and no pdfs platform to make students’s lives easier.
Reference Books:
- Sharp J. Good Pharmaceutical Manufacturing Practice: Rationale and Compliance. CRC Press 2005
- Haider SI. Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, andGLP Compliance. St. Lucie Press 2002
- Swarbrick J. Encyclopedia of Pharmaceutical Technology. Informa Healthcare 2007
- Kolman J, Meng P, Scott G. Good Clinical Practice: Standard Operating Procedures forClinical Researchers. Wiley 1998
- Signore AA, Jacobs T. Good Design Practices for GMP Pharmaceutical Facilities. Taylor&Francis Group 2005
Unit I
For the complete syllabus, results, class timetable, and many other features kindly download the iStudy App
It is a lightweight, easy to use, no images, and no pdfs platform to make students’s lives easier.
Unit II
Quality review and batch release document of finished products, annual product quality review and parametric release, Audits, quality audits of manufacturing processes and facilities, audits of quality control.
Unit III
Good documentation practices, route cause analysis, corrective action preventive action (CAPA), out of specifications (OOS) and out of trend (OOT), Clinical studies- ICH GCP (E6) guidelines, post marketing surveillance, Pharmacovigilance
Unit IV
BABE (bioavailability and bioequivalence) studies, Concepts and management of contract manufacturing guidelines, Statistical Tools for Quality Control and Precision, Tools of Problem Solving and Continuous Improvement.
Unit V
Introduction, scope and importance of IPR, Concept of trade mark, copyright and patents Product registration guidelines – CDSCO, USFDA, Concept of ISO (9001):(2008), (14000), OSHAS guidelines, Quality Strategy for Indian Industry, Brief concept of IND, NDA, ANDA, SNDA and PAT.
For the syllabus of all the subjects of B.Tech Biotechnology 7th Sem, 2021-22 scheme do visit Biotechnology 7th Sem syllabus subjects.
For the complete syllabus, results, class timetable, and many other features kindly download the iStudy App
It is a lightweight, easy to use, no images, and no pdfs platform to make students’s lives easier.