Quality Control & Regulatory Affairs detail syllabus for Biotechnology (Biotech), 2019-20 scheme is taken from AKTU official website and presented for AKTU students. The course code (RBT072), and for exam duration, Teaching Hr/Week, Practical Hr/Week, Total Marks, internal marks, theory marks, and credits do visit complete sem subjects post given below.
For all other biotech 7th sem syllabus for b.tech 2019-20 scheme aktu you can visit Biotech 7th Sem syllabus for B.Tech 2019-20 Scheme AKTU Subjects. For all other Departmental Elective-III subjects do refer to Departmental Elective-III. The detail syllabus for quality control & regulatory affairs is as follows.
Unit I
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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
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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.
Reference Books:
- Sharp J. Good Pharmaceutical Manufacturing Practice: Rationale and Compliance. CRC Press; 2005.
- Chow SC. Encyclopedia of Biopharmaceutical Statistics. Marcel Dekker; 2003. Page 6 of 16
- McCormick K. Quality (Pharmaceutical Engineering Series). Butterworth-Heinemann; 2002.
- Gad SC. Pharmaceutical Manufacturing Handbook: Production and Processes. John Wiley & Sons; 2008.
- Willig SH, Stoker JR. Good manufacturing practices for pharmaceuticals: a plan for total quality control. Marcel Dekker; 1997.
- Signore AA, Jacobs T. Good Design Practices for GMP Pharmaceutical Facilities. Taylor &Francis Group; 2005.
- Sarker DK. Quality Systems and Controls for Pharmaceuticals. John Wiley & Sons; 2008.
- Haider SI. Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance. St. Lucie Press; 2002.
- Steinborn L. GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, Sixth Edition, (Volume 1 – With Checklists and Software Package). Taylor & Francis; 2003.
- Kolman J, Meng P, Scott G. Good Clinical Practice: Standard Operating Procedures for Clinical Researchers. Wiley; 1998.
For detail syllabus of all other subjects of B.Tech Biotech, 2019-20 regulation do visit Biotech 7th Sem syllabus for 2019-20 Regulation.
Don’t forget to download iStudy for the latest syllabus, results, class timetable and more.