Biotechnological Products and Its Validation detailed syllabus for Biotechnology (BioTech) for 2021 regulation curriculum has been taken from the Anna Universities official website and presented for the BioTech 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 Biotechnology 6th Sem scheme and its subjects, do visit BioTech 6th Sem 2021 regulation scheme. For Professional Elective-VII scheme and its subjects refer to BioTech Professional Elective-VII syllabus scheme. The detailed syllabus of biotechnological products and its validation is as follows.
Unit I
Download the iStudy App for all syllabus and other updates.
Unit II
VALIDATION OF PHARMACEUTICAL PRODUCTION 9
Introduction to Pharmaceutical Validation, Scope & merits of Validation, Validation and calibration of Master plan, ICH & WHO guidelines for calibration and validation of equipm ents, Validation of specific dosage form, Types of validation. Government regulation, Manufacturing Process Model, URS, DQ, IQ, OQ & P.Q. of facilities, Analytical method validation
Unit III
VALIDATION OF FOOD NEUTRACEUTICALS AND COSMETICS 9
Microbiological quality control for Nutraceuticals.
Unit IV
Download the iStudy App for all syllabus and other updates.
Unit V
BIOTECHNOLOGY PROCESS AND EQUIPMENT VALIDATION 9
Process validation, General considerations for process equipments, Regulatory requirements for process validation, Documentation, Analytical methods.
Text Books:
- Pharmaceutical Process Validation; By Fra. R. Berry and Robert A. Nash
- Analytical Method validation and Instrument Performance Verification by Churg Chan, Heiman Lam, Y.C. Lee, Yue. Zhang, Wiley Inter Science.
- Book: Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products, Douglas J. Ball, Daniel L. Norwood, Cheryl L. M. Stults and Lee M. Nagao,
- Book: Medical Device 1st edition, Seeram Ramakrishna Lingling Tian Charlene Wang Susan Liao Wee Eong Teo, Woodhead Publishing, Hardcover ISBN: 9780081002896.
- Book: Biomaterials, Medical Devices and Combination Products: Biocompatibility Testing and Safety Assessment, Shayne Cox Gad, Samanta Gad-McDonald, CRC Press
- Fermentation Microbiology and Biotechnology by M. El-Mansi and C.Bryce
- Process Validation: General Principles and Practices-FDA Guidelines
For detailed syllabus of all the other subjects of Biotechnology 6th Sem, visit BioTech 6th Sem subject syllabuses for 2021 regulation.
For all Biotechnology results, visit Anna University BioTech all semester results direct link.