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생명과학 eQMS 15개 항목

Stability Program Checklist (ICH Q1A / 21 CFR 211.166)

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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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