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Quality, safety and regulatory · Stability

“One result in our stability study looks different from the earlier ones, and we don't know whether it's a trend or just scatter.”

Stability data evaluation: detect OOT and estimate shelf life

Stability data grows with every time point, and an unusual value is often noticed only once it is already out of specification. CovaSyn evaluates your data across all batches and storage conditions, detects out of trend results early and estimates shelf life under ICH Q1E. You receive a report with justification that your expert reviews and signs off.

Starting point

When you need this

  • An assay or impurity result departs from the previous course but is still within specification.
  • Shelf life is to be extended, and it is open whether the existing data supports it.
  • Several batches are to be evaluated together, and nobody knows whether they can be pooled.
  • Accelerated data is available, and you want to know what it means for storage at 25 °C.

If nothing changes

What it costs when the case stays open

  • A trend recognised too late ends as an OOS with an investigation and a blocked batch.
  • A weakly justified shelf life leads to authority questions or a shorter shelf life than possible.
  • Manual evaluation in spreadsheets ties up your analytical team again at every new time point.

Result

What you get

  • Trend and OOT per batch

    The course of every test parameter over time, with values outside the expected trend flagged and the distance to the specification limit.

  • Shelf life under ICH Q1E

    Estimated shelf life from regression with a 95 percent confidence bound, with the assumptions and the permitted extrapolation stated openly.

  • Poolability check

    A statistical test of whether batches may be evaluated together, and which batch limits shelf life if they may not.

  • Accelerated data put in context

    Degradation rates at different temperatures, Arrhenius temperature dependence and significant change under ICH Q1A(R2), where the data supports it.

How it works

From an open case to a signed-off report

  • 1. Describe the case

    In the initial call, 30 minutes on Microsoft Teams. We tell you honestly whether we can solve your problem.

  • 2. Send the data

    Confidential from the start. We run the evaluation, typically within 5 working days once we have your data.

  • 3. Sign off the report

    You receive the result with reasoning and input data. Your expert reviews and approves it.

CovaSyn

What we evaluate for this

Every number is calculated, not estimated. Every evaluation is documented with its input data and reasoning, so your expert can review and sign it off.

  • Trend and OOT detection across all batches

    Unusual values are checked against the course of their own batch and the comparison batches, not only against the specification.

  • Shelf life estimated with justification

    Shelf life under ICH Q1E with confidence bound, poolability and a diagnostic check of whether the evaluation fits the data.

  • Degradation kinetics and temperature

    Degradation rates per condition and a prediction for the storage temperature from accelerated data, with its uncertainty.

Audience

Who it is for

For analytical, QC, stability and regulatory affairs teams at contract labs, CDMOs and generics manufacturers who evaluate stability studies continuously or justify shelf life to authorities.

What the computation does not replace

  • The evaluation can only be as good as the data. With few time points the confidence bound stays wide and extrapolation under ICH Q1E is limited.
  • Accelerated data can only be transferred if the degradation mechanism is the same at all temperatures. If it is not, we say so in the report.
  • Whether an OOT triggers an investigation and which shelf life is filed is decided by your QA or expert.

Insights

Read on

Questions

Common questions

What is the difference between OOT and OOS?

OOS means a result is outside the specification. OOT means a result is within specification but does not fit the previous course of the batch or of comparable batches. OOT is the early warning that can announce a later OOS.

How do I calculate shelf life under ICH Q1E?

A regression over time is fitted for each test parameter, and shelf life is the point where the 95 percent confidence bound crosses the specification. Before that, poolability of the batches is checked. CovaSyn performs the calculation and shows every step.

When can I pool stability data from several batches?

Under ICH Q1E, when slopes and intercepts of the batches do not differ statistically, usually tested at a significance level of 25 percent. Otherwise the least favourable batch determines shelf life.

Can I infer shelf life from accelerated data?

To a limited extent. With degradation rates at several temperatures, the rate at storage temperature can be estimated via Arrhenius if the degradation mechanism stays the same. For the shelf life you file, authorities usually require real-time data.

Who can evaluate our stability data?

CovaSyn does this as Done-for-You: you describe product and study in the initial call, we agree on scope, and you typically receive the report within 5 working days once we have your data. Handled confidentially from the start.

Quality, safety and regulatory

Related problems we solve

Next step

Tell us about your stability study.

30 minutes on Microsoft Teams with the CovaSyn team. If it is not a fit, we will say so.