Quality Control & Standardization Of Herbals Book B.Pharm 8th Semester

                                                                                         Syllabus

                                      Quality Control & Standardisation of Herbals

                                                                   (Course Code: BP806ET)

Module 01                                                                                         10Hours

·         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.

Module 02                                                                                        10 Hours

·         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.

Module 03                                                                                        10 Hours

·         EU and ICH Guidelines for Quality Control of Herbal Drugs.

·         Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines.

Module 04                                                                                        08 Hours

·         Stability Testing of Herbal Medicines.

·         Application of Various Chromatographic Techniques in Standardisation of Herbal Products.

·         Preparation of Documents for New Drug Application and Export Registration

·         GMP Requirements and Drugs & Cosmetics Act Provisions.

Module 05                                                                                        07 Hours

·         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 Standardisation of Herbal Products.