Curriculum | QUALITY CONTROL AND STANDARDIZATION OF HERBALS (THEORY) | B. Pharmacy

Course: B Pharmacy   Year/ Semester: 4th   / 8th
Name of the subject:  QUALITY CONTROL AND STANDARDIZATION OF HERBALS   (THEORY)
Subject Code:  BP806ET
Unit Topic (Contents) Learning Objective ( By the end of lesson should be able to) Teaching Guidelines

 

Methodology 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

know WHO guidelines for quality control of herbal drugs

 

Identification tests for drugs – Pharmaceutical substances, Medicinal plants materials and dosage forms

WHO Guidelines for Quality control of drugs

ü  Determination of Foreign Matter

ü  Macroscopic and microscopic examinations

ü  Determination of ash

ü  Thin layer Chromatography

ü  Determination of Extractable Matter

ü  Determination of water and volatile Matter

ü  Determination of Bitterness Value etc.

Evaluation of commercial crude drugs intended for use

 

 

—Didactic lectures

—Power point presentations

 

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.

 

To learn CGMP, GAP and GLP in traditional system of medicines.

know Quality assurance in herbal drug industry

Complete theoretical aspects related to GMP and GLP.

 

 

Quality control methods for standardization of herbal drugs

—Didactic lectures

—Power point presentations

—Visit to herbal Industry

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

 

ICH guidelines for quality control of herbals

Research guidelines for herbals

ü  General considerations

ü  Legal Consideration

ü  Ethical consideration

ü  Traditional Knowledge of herbal medicines

ü  Regulatory requirements

ü  Purposes of research

ü  Selection of research projects

ü  Research approaches

ü  Assuring access to relevant database

— Didactic lectures

—  Power point presentations

 

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.

Know  the regulatory approval process and their registration in Indian and international markets Stability studies

ü  Accelrated stability studies

ü  ICH guidelines for stability studies

Application of various chromatographic techniques like HPLC, HPTLC, GC, LC-MS, GC-MS, Flash chromatography etc

CDSCO guidelines for NDA-New Drug Application

Documentary requirements for filing NDA

—–Didactic lectures

—-Power point presentations

 

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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

Enumerate regarding the regulatory aspects in the pharmaceutical industries. 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

—Didactic lectures

—-Power point presentations

 

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Admission 2017