B.Pharmacy 8th Semester Quality Control and Standardization of Herbals notes covering WHO, EU, and ICH guidelines, herbal drug evaluation, cGMP, GAP, GACP, stability testing, chromatographic techniques, pharmacovigilance, regulatory requirements, and herbal pharmacopoeias. Exam-oriented and easy to understand.
Quality Control and Standardization of Herbals Overview
| Bachelor of Pharmacy | |||||||
| Semester | 8th Semester | Subject | Quality Control and Standardization of Herbals | ||||
| Syllabus | |||||||
| Unit 1st | Basic tests for drugs – Pharmaceutical substances, medicinal plant materials and dosage forms WHO guidelines for quality control of herbal drugs. Evaluation of commercial crude drugs intended for use. | ||||||
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| Unit 2nd | Quality assurance in the 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 | ||||||
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| Unit 3rd | EUand ICH guidelines for qualitycontrol of herbal drugs. Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines | ||||||
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| Unit 4th | Stability testing of herbal medicines. Application of various chromatographic techniques in the standardisation of herbal products. Preparation of documents for new drug application and export registration GMPrequirements and Drugs & Cosmetics Act provisions. | ||||||
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| Unit 5th | 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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Unit Summary
Quality Control and Standardization of Herbals in B.Pharmacy 8th semester focuses on ensuring the quality, safety, and efficacy of herbal drugs and formulations. The subject covers basic evaluation tests for herbal raw materials, medicinal plants, and dosage forms, along with WHO guidelines for quality control. It explains quality assurance practices such as cGMP, GAP, GMP, GLP, and GACP in traditional systems of medicine.
Students learn about EU and ICH guidelines, safety and efficacy evaluation, stability testing, and the use of chromatographic techniques for standardization. The syllabus also includes regulatory requirements, Drugs & Cosmetics Act provisions, pharmacovigilance of herbal medicines, comparison of herbal pharmacopoeias, and the role of chemical and biological markers. These notes are structured for clear understanding, practical relevance, and effective university exam preparation.
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