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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
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