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Conservation

Compilation of herbal plants (description, geographical distribution, taxonomy, line drawings), biodiversity and herbarium.

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Research & Publication

Description of herbal and T&CM research, searchable publication and process from medicinal plant discovery to clinical trial in producing a high-quality registered herbal drug.

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Traditional & Complementary Medicine (T&CM)

 

Definition and description of therapies, policy, training and education, research in the practise of (T&CM) and integrated medicine system.           

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News Update

Forthcoming Events

2018 International Conference on Biotechnology and Bioengineering

From Wed, 24. October 2018 Until Fri, 26. October 2018

Green Extraction of Natural Products 2018

From Mon, 12. November 2018 Until Tue, 13. November 2018

World Congress on Bioorganic and Medicinal Chemistry

From Mon, 12. November 2018 Until Tue, 13. November 2018

International Conference on Natural Products, Medicinal Plants and Traditional Medicines

From Thu, 15. November 2018 Until Fri, 16. November 2018

30th International Symposium on the Chemistry of Natural Products and The 10th International Congress on Biodiversity

From Sun, 25. November 2018 Until Thu, 29. November 2018

Pharmaceutical development

Pharmaceutical Development

The aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product. Elements in pharmaceutical development:

  • Quality Target Product Profile
  • Critical Quality Attributes (CQA)
  • Risk Assessment: Linking Material Attributes and Process Parameters to Drug Product CQAs
  • Design space
  • Control strategy
  • Product lifecycle management and continual improvement

Steps

Aims

Manufacturing process

Formulation development

  • Description of dosage form.
  • Identification of overages or degradation products.

Manufacturing control

  • Control of materials.
  • Control of critical steps and intermediates.
  • Process validation and/or evaluation.
  • Suitability of container closure system.
  • Studies of key parameters which may have influence of the herbal substance.
  • Microbiological attributes.
  • Justification on non-standardisedsterilisation processes.

Process Control

Qualitative and quantitative analytical method development and validation

  • Determination of chemical reference substance or certified material.
  • Specification of tests and acceptance criteria with justification.
  • Analysis of batch-to-batch variation of plant material.
  • Stability of analytical method in identification, analysis of composition and function in monitoring.
  • Container closure system analysis.
  • Analytical performance characteristic for method validation:
  1. Accuracy
  2. Precision (Repeatability, intermediate precision, reproducibility)
  3. Specificity
  4. Detection limit
  5. Quantitation limit
  6. Linearity
  7. Range
  8. Robustness

Quality control and stability testing protocol development

  • Organoleptic analysis (appearance, odor, taste)
  • Purity testing:
  1. Foreign matters
  2. Ash contents
  3. Loss on drying
  4. Extractive value
  • Safety testing:
  1. Limit test for heavy metals
  2. Mircobial limits (Total yeast and mould count, total bacterial count, bile-tolerant gram negative bacteria)
  3. Limit test for specific pathogens
  • Stability testing:
  1. Photostability study
  2. Long-term storage condition (real time, accelerated time, stress studies)
  3. Appearance, analytical tests (hardness, friability, etc) and degradation product measurement.
  4. Container closure system (type, thickness,moisture permeability coefficient)
  • Certificate of Analysis

Note: Definitions were quoted from [4], [5], [6] and [7].

References

  1.   Guidance for Industry. Botanical Drug Products. U.S Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). June 2004.
  2.   Drug Registration Guidance Document (DRGD). Appendix 6: Guideline on Regulatory Control of Active Pharmaceutical Ingredients (API). January 2013. National Pharmaceutical Control Bureau, Kuala Lumpur
  3.   Guidelines on Good Manufacturing Practice for Traditional Medicines and Health Supplements. First edition.2008. National Pharmaceutical Control Bureau, Kuala Lumpur.
  4.   The ASEAN Common Technical Dossier (ACTD) For the Registration of Pharmaceuticals for Human Use. Part II: Quality.
  5.   ASEAN Guidelines for Validation of Analytical Procedures.
  6.   ASEAN Guidelines on Stability of Drug Product. 2005.
  7.   International Conference on Harmonisation (ICH) Tripartite Guideline. Pharmaceutical Development Q8 (R2). August 2009.

Explore Further

Consumer Data

Consumer data including medicinal herbs, dietary supplement monographs, health condition monographs and interactions and depletions.                                    

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Professional Data

Professional data organized into medicinal herbs, dietary supplement monographs, health condition monographs, T&CM herbs, formulas, health conditions, interactions and depletions.

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International Data

We offer International linkages to provide extensive content pertaining to many facets of T&CM as well as Integrated Medicine. Please register for access.    

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