On-going Stability

Details

Unlike the initial stability studies submitted at authorisation, the on-going stability programme monitors batches actually produced after marketing, through to the end of shelf life; EU GMP Chapter 6 §6.27 gives its purpose as confirming that the product remains, and can be expected to remain, within specification under the labelled storage conditions. §§6.29–6.32 require a written protocol and report following the rules of Chapter 4, qualified stability chambers, a protocol running to the end of shelf life that covers the number of batches, tests, acceptance criteria, testing frequency, and storage conditions, and, unless otherwise justified, at least one batch per year per strength and per primary packaging type so that trend analysis is possible; §6.33 requires additional batches after significant changes or deviations in process or packaging, and after rework, reprocessing, or recovery. 21 CFR 211.166 requires a statistically sound number of samples and test intervals, testing in the marketed container closure, and results reflected in the storage conditions and expiry date. Inspections cite the absence of the programme or of a written protocol, missing annual batches, and out-of-specification or out-of-trend results that were not carried into an assessment of product on the market.

Related sections

Related terms

Real inspection findings

Findings from regulators' inspection documents in which this term appears.

1. Failure to design a documented, on-going stability testing program to monitor the stability characteristics of API and to use the results to confirm appropriate storage conditions and retest or expiry dates.

   FDA · FDA Warning Letter · 2024-12-17

2. Failure to design an adequate documented, on-going stability testing program to monitor the stability characteristics of API and to use the results to confirm appropriate storage conditions and retest or expiry dates.

   FDA · FDA Warning Letter · 2024-04-09

3. The firm does not conduct on-going stability studies for any finished drug products which are manufactured and distributed to provide assurance that the established expiry dates of 15 days, 30 days, and 45 days remain valid.

   FDA · FDA 483 · 2024-01-17

Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.