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 |
|
| Manufacturing control |
|
|
| Process Control | Qualitative and quantitative analytical method development and validation |
Analytical performance characteristic for method validation:
|
| Quality control and stability testing protocol development | Organoleptic analysis (appearance, odor, taste) Purity testing:
Safety testing:
Stability testing:
|
Note: Definitions were quoted from [4], [5], [6] and [7].
References
- 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.
- Drug Registration Guidance Document (DRGD). Appendix 6: Guideline on Regulatory Control of Active Pharmaceutical Ingredients (API). January 2013. National Pharmaceutical Control Bureau, Kuala Lumpur.
- Guidelines on Good Manufacturing Practice for Traditional Medicines and Health Supplements. First edition.2008. National Pharmaceutical Control Bureau, Kuala Lumpur.
- The ASEAN Common Technical Dossier (ACTD) For the Registration of Pharmaceuticals for Human Use. Part II: Quality.
- ASEAN Guidelines for Validation of Analytical Procedures.
- ASEAN Guidelines on Stability of Drug Product. 2005.
- International Conference on Harmonisation (ICH) Tripartite Guideline. Pharmaceutical Development Q8 (R2). August 2009.
