B.Pharm Quality Control and Standardization of Herbals Notes

QUALITY CONTROL AND STANDARDIZATION OF HERBALS UNIT-WISE NOTES – BP806ET

Unit – 1

• 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 – 2

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

Unit – 3

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

Unit – 4

• 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 – 5

• 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