This is a ready-to-use decision checklist for the question that has to be answered before any validation, verification, or transfer protocol gets written: which pathway applies to this method, for this article, right now. A QC lab standing up many methods needs a fast, auditable answer per method, not a re-read of the underlying guidance every time. Replace every <<FILL: ...>> placeholder with your own specifics. A filled specimen follows the template. This is general guidance to adapt, not regulatory advice; confirm the current USP-NF edition and the cited regulation before you rely on them.
Why this record exists
The three pathways, full validation, compendial verification, and transfer, sit downstream of a single scoping question, and getting that question wrong is a documentation problem that shows up much later: a method titled “verification” that is actually an undisclosed modification, a method transferred without a comparative study because someone assumed a verification already covered it, or a compendial method validated from scratch when a leaner verification would have been correct and defensible. This checklist forces the scoping decision into its own short, signed record, completed before the heavier document (protocol) exists, so the heavier document inherits a decision that was actually reasoned through rather than assumed.
Use one completed record per method, per article. A method used for more than one product, or a product tested by more than one method, gets a separate record for each combination.
Document control header
| Field | Entry |
|---|---|
| Title | Validate / Verify / Transfer Decision: <<FILL: method name / attribute>> |
| Document number | <<FILL>> |
| Article (product / substance) | <<FILL>> |
| Method source document | <<FILL: monograph number and edition, or in-house method ID>> |
| Requesting lab / site | <<FILL>> |
| Author | <<FILL>> |
| Date | <<FILL>> |
1. Is the method published in an official compendium
| Question | Answer |
|---|---|
| Is the procedure, as you intend to run it, published in USP-NF, Ph. Eur., JP, or another official compendium recognized for this article’s registration? | <<FILL: Yes / No>> |
| If Yes, which compendium, chapter or monograph number, and current edition/supplement? | <<FILL>> |
| If No, this is a non-compendial method | Go to line 4 (validate) |
2. If compendial, has it been changed beyond the allowable adjustments
| Question | Answer |
|---|---|
| Have you changed anything beyond the adjustments USP <621> (or the equivalent Ph. Eur. 2.2.46 provision) permits without revalidation: mobile phase beyond the stated relative limit, column chemistry, detection mode, or the separation principle itself? | <<FILL: Yes / No>> |
| If Yes, list each change and whether it is inside or outside the allowable limits, with the specific clause reference | <<FILL>> |
| Does system suitability, as defined by the method, still pass with the conditions you intend to use? | <<FILL: Yes / No / Not yet tested>> |
| If any change is outside the allowable limits, this is a new method for the changed characteristics | Go to line 4 (validate the affected characteristics) |
3. Is the method moving between two labs, or is this the first use here
| Question | Answer |
|---|---|
| Is this procedure already validated or verified at a sending lab (a different site, a CMO, or a contract lab), and is it now moving to a receiving lab? | <<FILL: Yes / No>> |
| If Yes, name the sending lab and the validation or verification record it relies on | <<FILL>> |
| Is this the first time this procedure will be used at this lab for this article, with no sending lab involved? | <<FILL: Yes / No>> |
4. Decision
Work the three questions above in order. Record which single pathway applies and why. Do not select more than one pathway for the same method and article without a stated reason (for example, a transfer that also requires validating a portion changed beyond <621> limits during the transfer).
| If | Then | Governing reference |
|---|---|---|
| Not from an official compendium, or changed beyond allowable adjustments | Full validation (or validation of the changed characteristics) | ICH Q2(R2); USP <1225> |
| From an official compendium, within allowable adjustments, moving between two qualified labs | Transfer | USP <1224>; ICH Q14 |
| From an official compendium, within allowable adjustments, first use at this lab, no transfer involved | Verification | USP <1226> |
| Field | Entry |
|---|---|
| Pathway selected | <<FILL: Validation / Verification / Transfer / combination, state which>> |
| One-line rationale | <<FILL>> |
| Document this decision feeds | <<FILL: protocol ID, once written>> |
| Special cases checked (sterility <71>, endotoxin <85> suitability tests handled outside this pathway) | <<FILL: N/A or which one applies>> |
| Multiple strengths or presentations of this article in scope of this decision | <<FILL: list, or state "single strength/presentation only," see the article's bracketing guidance for a family>> |
| Other pharmacopeias this article is also registered against | <<FILL: list, or "US only." If more than one and monographs differ, a separate decision record is needed per compendium>> |
5. Approvals
| Role | Name | Signature | Date |
|---|---|---|---|
| Author (QC SME) | <<FILL>> | ||
| Reviewer (method validation group) | <<FILL>> | ||
| Approver (QA) | <<FILL>> |
Filled specimen
A decision record for the example finished-product assay used throughout the paired article: a USP monograph assay, run with two excipients not in the monograph’s typical matrix, first use at this lab, no sending lab involved (illustrative).
| Question | Answer |
|---|---|
| Published in an official compendium? | Yes, USP-NF monograph assay, current edition |
| Changed beyond <621> allowable adjustments? | No; mobile phase, column, and flow rate are as published |
| System suitability passes as intended to be run? | Yes, confirmed in a pre-check run |
| Moving between two labs? | No |
| First use at this lab for this article? | Yes |
| Field | Entry |
|---|---|
| Pathway selected | Verification |
| One-line rationale | Compendial method, unmodified beyond published conditions, first use at this lab for this article; USP <1226> applies |
| Document this decision feeds | Verification protocol (see the paired protocol template) |
| Special cases checked | N/A; this is a chemical assay, not sterility or endotoxin |
| Multiple strengths or presentations in scope | Single strength only at this time; if additional strengths of the same qualitative formula are added later, complete a new decision record referencing the bracketing rationale in the risk assessment |
| Other pharmacopeias registered against | US only |
Conclusion (specimen). This method is compendial, unmodified, and new to this lab with no sending lab involved. The decision is verification under USP <1226>. This record is the trigger for writing the verification protocol and the characteristic-selection risk assessment; it is not a substitute for either.
Common findings this record prevents
- A method transferred without a comparative study because a verification was assumed to already cover the receiving lab.
- A modified method documented as a verification when the change went beyond <621> allowable adjustments, discovered only when an inspector compares the running conditions to the monograph.
- No record of why a given pathway was chosen, so a reviewer cannot tell whether the scoping question was actually asked.
- A method used for a second product or strength without a fresh decision record, on the assumption that the original verification travels automatically.
- Sterility or endotoxin testing routed into a <1226> verification instead of its own compendial suitability test.
How to adapt this checklist
- Complete one record per method, per article, before any protocol is drafted.
- Answer the three questions in order; do not skip to a preferred pathway.
- Keep the special-case row honest: sterility, endotoxin, and non-compendial in-house methods do not run through this checklist’s verification branch.
- When a method later changes strength, presentation, site, or compendial reference, complete a new decision record rather than assuming the old one still applies.
- File this record ahead of, and cross-referenced from, the protocol it feeds.