Syllabus | QUALITY CONTROL AND STANDARDIZATION OF HERBALS (Elective Subject) | B. Pharmacy

Course: B Pharmacy   Year/ Semester: 4th   / 8th
Name of the subject:  QUALITY CONTROL AND STANDARDIZATION OF HERBALS  (Elective Subject)                           (THEORY)
Subject Code:  BP806ET
S. No. Contents of the Topics             Domain Time(Hrs)
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

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10

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.  

Must Know

 

10
3 EU and ICH guidelines for quality control of herbal drugs. Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines Must Know 10
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.

 

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8
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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7

Admission 2017