What ICH Harmonised Tripartite Guideline Q8(R2) Pharmaceutical Development requires
This guideline requires pharmaceutical manufacturers to implement a systematic, science- and risk-based approach to product development, known as Quality by Design (QbD). This involves defining a Quality Target Product Profile (QTPP) and identifying Critical Quality Attributes (CQAs) to ensure the final product meets its intended quality, safety, and efficacy, as detailed in Section 2.
Pillar: Medical & Healthcare · Authority: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) · Version: 1.0.0 · Last updated:
Primary source: https://database.ich.org/sites/default/files/Q8_R2_Guideline.pdf
SHA-256 integrity: df2e8008db087bca4a3e5ffcf2f970d55a53509957d405c82a2b910a6a631c8c
Primary Citations — 6 traced to source
- ICH Q8(R2) Section 2.2: Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQAs)
- ICH Q8(R2) Section 2.3: Risk Assessment: Linking Material Attributes and Process Parameters to Drug Product CQAs
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