BP806 ET. QUALITY CONTROL AND STANDARDIZATION OF HERBALS Books
Ensuring consistency, purity, and efficacy of herbal products through:
– Authentication and identification
– Chemical and biological testing
– Standardization of extracts and active compounds
– Compliance with regulatory standards”
Course Content
Unit Title
Content
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
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 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
Learning Objectives
- 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
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