Quality Control and Standardization of Herbals – Theory detailed Syllabus Scheme for Bachelor of Pharmacy (B.Pharm), 2019 regulation has been taken from the University of Mumbai official website and presented for the Pharmacy students. For Course Code, Subject Name, Continuous Mode, SE Marks, SE Duration, Total, Marks, Duration in Hours, Total Marks, and other information, do visit full semester subjects post given below.
For all other Mumbai University B.Pharm 8th Sem Syllabus 2019 Pattern, do visit B.Pharm 8th Sem 2019 Pattern Scheme. The detailed syllabus scheme for quality control and standardization of herbals – theory is as follows.
BP806ET: Quality Control and Standardization of Herbals – Theory Syllabus for B.Pharm 8th Sem 2019 Pattern Mumbai University
Scope:
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Objectives
Upon completion of the subject student shall be able to;
- know WHO guidelines for quality control of herbal drugs
- know Quality assurance in herbal drug industry
- know the regulatory approval process and their registration in Indian and international markets
- appreciate EU and ICH guidelines for quality control of herbal drugs
UNIT I 10
Basic tests for drugs – Pharmaceutical substances, Medicinal plants materials and dosage forms WHO guidelines for quality control of herbal drugs. Evaluation of commercial crude drugs intended for use
UNIT -II 10
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UNIT -III 10
EU and ICH guidelines for quality control of herbal drugs. Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines
UNIT -IV 8
Stability testing of herbal medicines. Application of various chromatographic techniques in standardization of herbal products. Preparation of documents for new drug application and export registration GMP requirements and Drugs & Cosmetics Act provisions.
UNIT -V 7
For the complete Syllabus, results, class timetable, and many other features kindly download the iStudy App
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Recommended Books: (Latest Editions
- Pharmacognosy by Trease and Evans
- Pharmacognosy by Kokate, Purohit and Gokhale
- Rangari, V.D., Text book of Pharmacognosy and Phytochemistry Vol. I , Carrier Pub., 2006.
- Aggrawal, S.S., Herbal Drug Technology. Universities Press, 2002.
- EMEA. Guidelines on Quality of Herbal Medicinal Products/Traditional Medicinal Products,
- Mukherjee, P.W. Quality Control of Herbal Drugs: An Approach to Evaluation of Botanicals. Business Horizons Publishers, New Delhi, India, 2002.
- Shinde M.V., Dhalwal K., Potdar K., Mahadik K. Application of quality control principles to herbal drugs. International Journal of Phytomedicine 1(2009); p 4-8.
- WHO. Quality Control Methods for Medicinal Plant Materials, World Health Organization, Geneva, 1998. WHO. Guidelines for the Appropriate Use of Herbal Medicines. WHO Regional Publications, Western Pacific Series No 3, WHO Regional office for the Western Pacific, Manila, 1998.
- WHO. The International Pharmacopeia, Vol. 2: Quality Specifications, 3rd edn. World Health Organization, Geneva, 1981.
- WHO. Quality Control Methods for Medicinal Plant Materials. World Health Organization, Geneva, 1999.
- WHO. WHO Global Atlas of Traditional, Complementary and Alternative Medicine. 2 vol. set. Vol. 1 contains text and Vol. 2, maps. World Health Organization, Geneva, 2005.
- WHO. Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants. World Health Organization, Geneva, 2004
For detail syllabus of all other subjects of Bachelor of Pharmacy (B.Pharm), 2019 regulation do visit B.Pharm 8th Sem Subjects syllabus for 2019 regulation.