SOP for Reviewing Analytical Reports and Data

In short: This example SOP gives a quality-control laboratory a structured way to review analytical reports against their supporting records. The reviewer checks identity, method, calculations, instrument data, results and approvals before the report is finalised.

Example in-house criterion (not a pharmacopoeial requirement): The roles, order of checks, checklist and approval points below are an illustrative template. Adapt them to the laboratory’s approved methods, quality system and authorisation matrix.

Objective

Describe a documented review of analytical reports and their supporting data for completeness, accuracy and traceability.

Scope

This example applies to quality-control results for starting materials, intermediates and finished products. Adapt it for the laboratory’s paper and electronic systems and for the tests performed at the site.

Responsibility

• Analyst: Complete the test using the current approved method and assemble the report with the supporting records.
• Designated reviewer: Check the report and supporting data, document questions or discrepancies, and return them for resolution when needed.
• Authorised approver: Approve or reject the report according to the site’s current quality-system responsibilities.

Procedure

1. Confirm the test and sample details. Check that the report identifies the sample, material or product, batch or lot, sample number, specification, test method and method version. Confirm that the listed analyst, dates, instruments, standards and reagents can be traced to the supporting records.

2. Check record completeness. Compare the report with the original worksheets and relevant instrument-generated records, such as chromatograms, spectra and balance printouts. Confirm that the documentation includes the observations, calculations, derived results and analyst identity needed to understand or recalculate the test (WHO TRS 1052, Annex 4 (2024), §§3.23 and 6.33–6.36).

3. Review electronic data where applicable. Check that data are attributable to the user, instrument and test, and that relevant metadata are available. Review applicable audit-trail entries alongside the record, including changes to data processing or chromatographic integration; check that any reprocessing has a documented rationale. FDA’s 2018 CGMP data-integrity guidance describes these controls for electronic records (Questions 1 and 7).

4. Verify calculations and transcription. Recalculate results when needed to confirm the formula, units, dilution factors, rounding and transfer of values into the report. Resolve discrepancies against the original source record; do not silently overwrite an entry.

5. Review chromatographic results when applicable. Confirm that the approved method and its system-suitability requirements were followed. Inspect the chromatogram and integration against the method, and check that all runs and processing changes relevant to the reported result are accounted for. Do not select integration settings simply to obtain a passing result (FDA, Data Integrity and Compliance With Drug CGMP, December 2018, Question 1(c); WHO TRS 1052, Annex 4 (2024), §6.33).

6. Compare results with the applicable specification. Verify that the result, units and conclusion match the current approved specification and method. If a result is out of specification or a discrepancy is found, pause report approval and follow the applicable investigation procedure before deciding whether additional testing is justified (WHO TRS 1052, Annex 4 (2024), §§6.75–6.82).

7. Complete the report review. Check that the report and its supporting records agree, that corrections are traceable, and that the conclusion follows from the reviewed results. The designated reviewer records their review and any resolution of discrepancies; final approval follows the site’s authorised process. WHO TRS 1052, Annex 4 (2024), §§5.9–5.10 and 6.84–6.86 describes laboratory responsibilities for review and approval of analytical reports.

8. File the completed record set. Store the report, worksheets, instrument data and review evidence under the approved records-control procedure. Keep batch documentation for at least one year after the expiry of the respective product batch; under EU GMP Part I Chapter 4 §4.11, keep it for at least five years after Qualified Person certification if that is longer. 21 CFR Part 211 §211.180(a) also requires at least one year after batch expiry for qualifying batch-specific records. Apply any longer local or marketing-authorisation period.

Training

Train personnel on the applicable approved procedure and on any test-specific review steps before they perform or approve those steps. Training assignment and documentation are defined by the site quality system.

Distribution

Maintain controlled copies for the quality-control and quality-assurance functions according to the site document-control procedure.

Annexure: example review checklist

Example in-house criterion (not a pharmacopoeial requirement): A site may adapt a checklist covering:

• sample and batch identity, approved method and specification;
• analyst, instrument, standards and reagent traceability;
• worksheets, original data, calculations, units and transcription;
• chromatograms, all relevant runs, system suitability and processing changes;
• result assessment, discrepancy investigation and authorised review.

See also the microbiological analytical data and report checklist, the analytical-report numbering SOP and the OOS laboratory investigation guide.

References

• World Health Organization. WHO Technical Report Series No. 1052, Annex 4: WHO Good Practices for Pharmaceutical Quality Control Laboratories (2024), §§3.23, 5.9–5.10, 6.33–6.36, 6.75–6.86. Official WHO publication and official guideline PDF.
• U.S. Food and Drug Administration. Data Integrity and Compliance With Drug CGMP: Questions and Answers, Guidance for Industry (December 2018), Questions 1 and 7. FDA guidance page and official guidance PDF.
• European Commission. EudraLex Volume 4, EU Guidelines for Good Manufacturing Practice, Part I, Chapter 4: Documentation (2011), §§4.8–4.12. Official Chapter 4 PDF.
• U.S. Food and Drug Administration. 21 CFR Part 211, §211.180(a), batch-specific record retention requirement; see also FDA’s current CGMP materials and cited compliance examples. FDA Basic CGMP Requirements.