Imperfect Pharmacy Notes 8th Semester
QUALITY CONTROL & STANDARDIZATION OF HERBALS
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.
OPEN UNIT 1
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.
OPEN UNIT 2
Unit 3
EU and ICH guidelines for quality control of herbal drugs.
Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines.
OPEN UNIT 3
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.
OPEN UNIT 4
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.