Stability Study Pull Schedule Worksheet (ICH Q1A)
A stability pull schedule tells the lab which samples to remove from which chamber on which date and how many units are needed. This worksheet plans pulls by batch, condition and time point, and totals the units so you can check the batch has enough material.
| Batch | Condition | Study | Study start | Time point (months) | Pull due date | Tests | Units per test set | Sets (incl. reserve) | Units to pull | Status | |
|---|---|---|---|---|---|---|---|---|---|---|---|
60 | |||||||||||
60 | |||||||||||
90 | |||||||||||
60 | |||||||||||
90 |
Typical ICH Q1A(R2) long term frequency for a 12 month study is every 3 months in year one, every 6 months in year two and annually after; accelerated is 0, 3 and 6 months. Enter your own protocol. Add a 1.5 or 2 sets factor for reserve and repeats. Always confirm the pull window (for example plus or minus 7 days) in the protocol.
Stability sample inventory linked to ERP
An optional outline for reconciling stability sample stock and pull dates with your ERP and LIMS.
Optional. The tool and every export work without this. No spam.
How to use the worksheet
Add a row for each batch, storage condition and time point in the protocol. Enter the study start date, time point in months, the due date, the tests and the units needed for one set of tests. The sets factor lets you include reserve units for repeats, and the units column multiplies them. Update the status as samples are pulled and tested. Export to Excel to build the chamber pull calendar or to paste into a LIMS stability module.
- Use the actual chamber placement date as study start
- Include reserve units for repeat and OOS testing
- Mark each pull status the day it happens
- Keep a chamber map and temperature log with the protocol
ICH Q1A(R2) in practice
ICH Q1A(R2) calls for long term testing at 25C/60%RH or 30C/65%RH or 30C/75%RH depending on climatic zone, accelerated testing at 40C/75%RH for six months, and intermediate testing at 30C/65%RH if a significant change occurs under accelerated conditions. Testing frequency for long term is normally every three months in the first year, every six months in the second, then annually. Use at least three primary batches for a registration submission.
Planning sample quantities
Count units for each test across every condition and time point, then add a reserve. Dissolution, assay and related substances may each use different unit counts, and microbial or container closure tests need separate units. A common planning error is to forget stress or photostability studies and retained samples. The total at the bottom helps decide the batch quantity to place on stability before the study begins.
Common mistakes and ERP notes
Frequent issues are missed pulls, pulls outside the allowed window, chamber excursions not assessed, and sample counts too small after an OOS retest. In SAP QM, Oracle or Epicor, stability batches are often set up as a separate inspection lot or sample stock with a dedicated storage location, so remaining inventory matches the plan. Report any OOT result early and link it to the OOS procedure.
Frequently Asked Questions
How many batches are needed for stability?
For a registration application ICH Q1A(R2) expects data on at least three primary batches of the drug product, made by a process representative of production, with two at least pilot scale. Commitment batches continue after approval.
What are the usual time points?
Long term studies are typically 0, 3, 6, 9, 12, 18, 24 months and annually after. Accelerated studies run 0, 3 and 6 months. Intermediate studies use 0, 6, 9 and 12 months when needed.
What is a pull window?
A pull window is the allowed tolerance around the scheduled pull date, often plus or minus 7 days for early time points and more for later ones. It is set in the protocol and exceeding it is recorded as a deviation.
How many units should I pull?
Enough for all tests at that time point plus a reserve for repeats, typically 1.5 to 2 times the minimum. Check the stability protocol for each test's requirement because dissolution and microbial tests use more units.
Netray can help sync stability sample inventory and pull dates between your ERP, LIMS and chamber records. The worksheet is complete without it.
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