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Guideline Title Purpose
Q8(R2) Pharmaceutical development QbD principles
Q9 Quality risk management Risk assessment
Q10 Pharmaceutical quality system Continuous improvement
Risk Management Tools (ICH Q9):
• FMEA (Failure Mode and Effects Analysis).
• Fishbone (Ishikawa) diagram.
• Fault tree analysis.
• HACCP (Hazard Analysis and Critical Control Points).
Key Terminologies:
• Assay: determination of active ingredient content.
• Disintegration: breakdown into particles.
• Dissolution: rate of drug release into medium.
• Friability: resistance to abrasion.
• Hardness: mechanical strength of tablet.
• Uniformity of content: individual content variation.
Appendix – Example Calculations:
1. Carr’s Index:
CI = [(Tapped density – Bulk density) / Tapped density] × 100
2. Hausner Ratio:
HR = Tapped density / Bulk density
3. Friability (%):
F = [(W₁ – W₂) / W₁] × 100
4. Dissolution Efficiency (%DE):
Area under dissolution curve up to time t, expressed as percentage of area of rectangle
representing 100% dissolution.
Example Specifications (BP/USP):
85
