This is a ready-to-use screening form, meant to be attached to (or built into) every change-control record for a product operating under ICH Q12. It exists to close the single most common Q12 finding: a change to an established condition implemented as an internal change because no one asked the question. Replace every <<FILL: ...>> placeholder with your own specifics. A worked specimen follows.
Instructions
Complete this form at the start of every change-control record for a marketed product. It must be completed and its outcome (regulatory path or internal path) confirmed before the change is implemented, not after.
Field table
| Field | Format | Required | Completed by | When |
|---|---|---|---|---|
| Change-control record number | <<FILL: CC-ID format>> | Yes | Change originator | At change initiation |
| Product / dossier | Free text | Yes | Change originator | At change initiation |
| Change description | Free text, specific enough to check against the PLCM | Yes | Change originator | At change initiation |
| Current PLCM version referenced | <<FILL: version, date>> | Yes | Change originator | At change initiation |
| Does the change touch a listed established condition? | Yes / No, with the specific EC row cited if Yes | Yes | Regulatory affairs (CMC) | Before risk assessment is finalized |
| If Yes, is the change covered by an approved PACMP? | Yes (protocol reference) / No | Yes if EC = Yes | Regulatory affairs (CMC) | Same step |
| Q9(R1) risk assessment reference | <<FILL: RA document number>> | Yes | Quality assurance | Before implementation |
| Regulatory path required | Submission required (category) / No submission, inside registered design space / N/A, not an EC | Yes if EC = Yes | Regulatory affairs (CMC) | Before implementation |
| Implementation authorized | Yes, date / No, pending regulatory step | Yes | Quality assurance | Before implementation |
| PLCM update required | Yes / No | Yes | Regulatory affairs (CMC) | At change closure |
| Effectiveness check due date | <<FILL: date>> | Yes | Quality assurance | At change closure |
Retention
Retain with the associated change-control record per the records retention schedule, for not less than <<FILL: retention period>>.
Filled specimen
Completed for the granulation end-point moisture widening example used in the parent article.
| Field | Entry |
|---|---|
| Change-control record number | CC-2026-0417 |
| Product / dossier | Tablet Product Alfa, NDA <<FILL>> |
| Change description | Widen granulation end-point moisture target from a single point (2.0% w/w LOD) to a range (1.5-2.5% w/w LOD) |
| Current PLCM version referenced | v4.2, 15 March 2026 |
| Does the change touch a listed established condition? | Yes, PLCM row “Granulation end-point moisture,” parameter-based EC |
| If Yes, is the change covered by an approved PACMP? | No |
| Q9(R1) risk assessment reference | RA-2026-0089 |
| Regulatory path required | Submission required, moderate / CBE-30 category, supported by the proven-acceptable-range study |
| Implementation authorized | No, pending regulatory step; submission filed 02 April 2026 |
| PLCM update required | Yes, on submission clearance |
| Effectiveness check due date | 90 days after implementation |
The record shows the screening question answered correctly before anything was implemented: the change touched a parameter-based EC with no PACMP to fall back on, so it went through the standard filing path rather than being absorbed as an internal change.
Common inspection findings this form prevents
- A change-control record with no field that asks whether an established condition is affected, so the determination depends on someone remembering Q12 exists.
- A change implemented before the regulatory path was confirmed, or before a required submission cleared.
- No cited PLCM version, so the reviewer cannot confirm the screening used the current established-conditions list.
- An effectiveness check never scheduled, so the change is approved but never confirmed to have worked as intended.
How to adapt this form
- Build this field set directly into your electronic change-control system as mandatory fields, not a separate paper form that can be skipped.
- Route the “Yes” outcome automatically to Regulatory Affairs for the regulatory-path fields; do not let a non-regulatory role complete them.
- Block the implementation-authorization field until the regulatory path is either confirmed satisfied or confirmed not required.
- Tie the PLCM-update field to an actual PLCM revision trigger, not a checkbox with no follow-through.