The CMC DeskAll guidesStability and quality ยท 9 min read
Stability sample management under ICH Q1A
A defensible stability program connects protocol commitments, representative samples, controlled storage, scheduled pulls, complete testing, and scientifically sound trend review.
In this guide
Begin with the approved protocol
Define batches, strengths, package configurations, conditions, time points, tests, acceptance criteria, and responsibilities. Commercial programs must reflect registered commitments and applicable regional requirements.
Protect sample identity and traceability
Use unambiguous labels, controlled chain of custody, reconciliation, and documented transfers. Store samples in the marketed or justified representative container-closure configuration.
Govern chambers and excursions
Map and qualify chambers, monitor continuously, control access, and maintain alarm response. Evaluate excursions by magnitude, duration, product sensitivity, packaging, and stability knowledge; an excursion does not automatically invalidate samples.
Execute pulls and testing on schedule
Define pull windows and record actual pull and test dates. Preserve raw data and link every result to the batch, condition, time point, method, analyst, and instrument.
Trend before failure
Review rates of change, batch-to-batch behavior, unusual sequences, and approaching limits. OOT criteria should be scientifically and statistically justified and distinct from OOS criteria.
Primary references
- ICH Q1A(R2), Stability Testing of New Drug Substances and Products
- 21 CFR 211.166, Stability testing