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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.