生命科学 eQMS 15 项
Stability Program Checklist (ICH Q1A / 21 CFR 211.166)
此检查清单为英文版。
Confirms the stability testing program supports expiration dating and storage conditions for drug products and substances. Use for stability protocol review and annual program assessment.
ICH Q1A(R2)21 CFR 211.166ICH Q1E
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Program Design
- Is there a written stability testing program to assess product characteristics over time? *
- Does the program include a bracketing/matrixing rationale where used?
- Are stability-indicating analytical methods validated and used? *
Storage Conditions
- Are long-term, intermediate, and accelerated conditions defined per the climatic zone? *
- Are stability chambers qualified, mapped, and monitored with alarms? *
- Record the current long-term storage condition (e.g., 25C/60%RH).
Sampling and Testing Intervals
- Are test intervals defined (e.g., 0, 3, 6, 9, 12, 18, 24 months for long-term)? *
- Are at least three primary batches placed on the long-term study for registration? *
- Is an appropriate number of the same container-closure system used as marketed? *
Results and OOS Management
- Are stability results reviewed against specification at each interval? *
- Are out-of-specification/out-of-trend stability results investigated? *
- Is a stability failure evaluated for impact on marketed batches and reporting? *
Shelf Life and Ongoing Commitment
- Is the expiration date/retest period justified by stability data and statistical analysis? *
- Is at least one batch per year placed into the ongoing (annual) stability program? *
- Record the approved shelf-life/expiry period.
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