What ICH Q1A(R2) Stability Testing of New Drug Substances and Drug Products requires
This guideline defines the core stability data package required for a new drug substance or drug product registration application within the ICH regions, specifying storage conditions, study durations, and data evaluation to establish a re-test period or shelf life. It applies to pharmaceutical manufacturers submitting New Drug Applications (NDAs) or Marketing Authorisation Applications (MAAs), as detailed in Section 2.1 General Principles.
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/Q1A%28R2%29%20Guideline.pdf
SHA-256 integrity: bb82bd7a49eb2c3849903923b40c033e60379bca3f9d2cb6047b2ee98e0773fe
Primary Citations — 6 traced to source
- ICH Q1A(R2), Section 2.1.2: Stress Testing
- ICH Q1A(R2), Section 2.1.3: Selection of Batches
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