July 24, 2024

806ET Quality Control and Standardization of Herbals Theory QCHS Sem 8 notes

Quality Control and Standardization of Herbals Theory QCHS Sem 8 notes

Unit I

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

Quality assurance in herbal drug industry of cGMP, GAP, GMP and GLP in the traditional system of medicine.
WHO Guidelines on current Good Manufacturing Practices (cGMP) for Herbal Medicines
WHO Guidelines on GACP for Medicinal Plants.

Unit III

EU and ICH guidelines for quality control of herbal drugs.
Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines

Unit IV

Stability testing of herbal medicines.Application of various chromatographic techniques
in the standardization of herbal products.
Preparation of documents for new drug application and export registration
GMP requirements and Drugs & Cosmetics Act provisions.

Unit V

Regulatory requirements for herbal medicines.
WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems
Comparison of various Herbal Pharmacopoeias.
Role of chemical and biological markers in standardization of herbal products

  1. Pharmacognosy by Trease and Evans
  2. Pharmacognosy by Kokate, Purohit and Gokhale
  3. Rangari, V.D., Text book of Pharmacognosy and Phytochemistry Vol. I , Carrier Pub., 2006.
  4. Aggrawal, S.S., Herbal Drug Technology. Universities Press, 2002.
  5. EMEA. Guidelines on Quality of Herbal Medicinal Products/Traditional Medicinal Products,
  6. Mukherjee, P.W. Quality Control of Herbal Drugs: An Approach to Evaluation of Botanicals. Business Horizons Publishers, New Delhi, India, 2002.
  7. 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.
  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.
  9. WHO. The International Pharmacopeia, Vol. 2: Quality Specifications, 3rd edn. World Health Organization, Geneva, 1981.
  10. WHO. Quality Control Methods for Medicinal Plant Materials. World Health Organization, Geneva, 1999.
  11. 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.
  12. WHO. Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants. World Health Organization, Geneva, 2004.

Final Year B Pharm Notes, Syllabus, Books, PDF Subjectwise/Topicwise

Final Year B Pharm Sem VIIBP701T Instrumental Methods of Analysis Theory
BP702T Industrial Pharmacy TheoryBP703T Pharmacy Practice Theory
BP704T Novel Drug Delivery System TheoryBP705 P Instrumental Methods of Analysis Practical
Final Year B Pharm Sem VIIBP801T Biostatistics and Research Methodology Theory
BP802T Social and Preventive Pharmacy TheoryBP803ET Pharmaceutical Marketing Theory
BP804ET Pharmaceutical Regulatory Science TheoryBP805ET Pharmacovigilance Theory
BP806ET Quality Control and Standardization of Herbals TheoryBP807ET Computer-Aided Drug Design Theory
BP808ET Cell and Molecular Biology TheoryBP809ET Cosmetic Science Theory
BP810ET Experimental Pharmacology TheoryBP811ET Advanced Instrumentation Techniques Theory
BP812ET Dietary supplements and NutraceuticalsPharmaceutical Product Development