SOP: Second-Person Review of Analytical and QC Laboratory Data

This is a ready-to-use SOP for the second-person review of laboratory data. Replace every <<FILL: ...>> placeholder with your own specifics, set your document numbers and dates, and route it through your normal document control and approval. A worked filled specimen follows. Verify each cited regulation against the current source before you rely on it.

Document control header

1. Purpose

This procedure defines how a qualified second person reviews analytical and QC laboratory data before the result is used, so that the record is accurate, complete, and compliant with the method, and so that changes visible only in electronic metadata (reprocessing, deletions, manual integrations) are detected. The review is the independent control that catches the honest mistake and deters the dishonest edit before data feeds a disposition decision.

2. Scope

This procedure applies to all GxP analytical and QC data generated at the sites in the header that supports a release, stability, or other quality decision, across chromatographic, spectroscopic, titrimetric, microbiological, and cell-based or plate-based techniques, and data produced by validated spreadsheets or LIMS calculations. It does not replace the batch disposition decision, governed by <<FILL: SOP-ID for disposition>>.

3. Responsibilities

4. Definitions

• Second-person review: an examination by a different, qualified, independent person of a result and everything behind it, per 21 CFR 211.194(a)(8) (accuracy, completeness, and compliance with established standards).
• Metadata / audit trail: the system-generated record of what happened to the data during acquisition and processing, in time order.
• Independent reviewer: a reviewer who did not generate the data and has no stake in passing the batch.

5. Procedure

5.1 Confirm independence

1. The reviewer must be a different qualified person from the analyst, signing as a uniquely identified individual (never a shared account).
2. Where full independence is constrained (for example a small laboratory), apply the documented compensating control in <<FILL: reference>>: a peer in another group, a supervisor who did not perform the test, or rotated reviewers. Silent self-review is not permitted.

5.2 Perform the review

Review, in this order, and record the outcome of each:

1. Chromatogram and integration (for separation techniques): open the actual data, not the PDF; confirm integration matches the validated method; list every manual integration the audit trail flags; for each, confirm it was flagged, has a documented and scientifically sound reason, and did not move a result across a specification limit without strong independent justification.
2. Run audit trail: read the trail for the run chronologically; flag every reprocess, re-integration, deletion, and sample-ID change; confirm each has an acceptable recorded reason and that the reported result traces to the final legitimate processing.
3. System suitability or system-check equivalent: confirm it was performed, passed against the method criteria, and passed before the dependent samples ran.
4. Sample-set / sequence completeness: reconcile every injection or determination to a documented purpose; confirm zero unexplained (orphan) runs.
5. Calculation: confirm the validated calculation was used; verify inputs against source; confirm rounding, significant figures, units, and the specification comparison.
6. OOS / OOT / aborts: confirm every failure or anomaly was handled through the proper channel with the original data retained.

For non-chromatographic techniques, apply the same six questions to the technique-specific system check, raw data, metadata, and calculation as defined in <<FILL: method-specific review guidance>>.

5.3 Evidence the review

1. Complete the analytical data review record (<<FILL: form / record ID>>), naming the specific checks performed, with an explicit field stating whether the audit trail was reviewed, for what period, and what was found.
2. Sign and date the record as a uniquely identified individual.

5.4 Handle exceptions

1. Return the result to the analyst for correction, or escalate, when any check fails.
2. Open a <<FILL: deviation / OOS reference>> when a failure could affect a result or a quality decision, and do not release the data until it is resolved.

5.5 Timing

The second-person review, including the audit trail, must be complete before the result feeds disposition. A review performed after release is not a control.

6. Acceptance criteria

• The reviewer is a different, qualified, independent, attributable person.
• All six checks (or their technique equivalents) were performed and recorded.
• The audit trail was reviewed, and the record states its scope and findings.
• Every manual integration and every failure was scrutinized and defensible.
• The review was completed before disposition.

7. References

21 CFR 211.194(a)(8) (second-person review of laboratory records for accuracy, completeness, and compliance). FDA Data Integrity and Compliance With Drug CGMP: Questions and Answers (final, December 2018). MHRA GXP Data Integrity Guidance and Definitions (March 2018). PIC/S PI 041, Good Practices for Data Management and Integrity. EU GMP Annex 11 (computerized systems) and Chapter 4 (documentation).

Confirm the current version and clause numbers of each reference before issue.

8. Records generated

• Analytical data review record (<<FILL: form / record ID>>)
• Any deviation or OOS raised from the review

9. Revision history

10. Approvals

Filled specimen

Illustrative completed review of an HPLC assay. Names and numbers are examples.

The two lines that separate this from a paper review are the sequence-completeness line and the explicit audit trail field. Because both are filled with a scope and a finding, an inspector pulling the same run months later can confirm the review genuinely reached the metadata.

Common findings this SOP prevents

• The data review did not include the audit trail, so reprocessing and deletions went undetected.
• A “second person” who is the analyst’s subordinate or a mutual rubber-stamp, with no documented compensating control.
• A manual integration that moved a result across a limit, passed through review without scrutiny.
• System suitability accepted out of order, or a failed suitability followed by reported sample data.
• The review completed after the batch was released, making it a formality.

How to adapt this SOP

1. Set your document number, owner, and effective date.
2. Point the cross-references to your real disposition, deviation, and OOS procedures and your compensating-control document.
3. Attach your analytical data review record and your manual-integration justification form.
4. Add the technique-specific review points your laboratory actually runs (dissolution, ELISA, titration, microbiology).
5. Confirm every regulation in section 7 against the current published version before issue.