Elixir Department: SOP for Review of Analytical Data – V 2.0

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Elixir Department: SOP for Review of Analytical Data – V 2.0

Standard Operating Procedure for Review of Analytical Data in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/247/2025
Supersedes SOP/ELX/247/2022
Page No. Page 1 of 8
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To establish a standardized procedure for the review of analytical data generated during testing of raw materials, in-process samples, and finished elixir products to ensure completeness, accuracy, and compliance with cGMP and data integrity standards.

2. Scope

This SOP is applicable to all Quality Control (QC) personnel and Quality Assurance (QA) reviewers involved in the generation, review, approval, and archival of analytical data within the Elixir Department.

3. Responsibilities

  • QC Analyst:
    • Ensure data is recorded contemporaneously, completely, and accurately in accordance with approved procedures.
  • QC Reviewer:
    • Perform first-level review of analytical results, raw data, calculations, and instrument printouts.
  • QA Reviewer:
    • Conduct second-level review, verify compliance with specifications and approve results for release.
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4. Accountability

The Head of Quality Control is accountable for ensuring adherence to this SOP. The Head of Quality Assurance is responsible for ensuring regulatory compliance and integrity of analytical

data.

5. Procedure

5.1 General Requirements

  1. All analytical data shall be recorded in indelible ink or electronically using validated systems.
  2. Data must be attributable, legible, contemporaneous, original, accurate (ALCOA+).
  3. Each page shall be signed and dated by the person performing the activity.

5.2 QC First-Level Review

  1. Check that all test parameters have been recorded and calculated correctly.
  2. Verify:
    • Instrument calibration status on the date of analysis
    • Standard preparation records and validity
    • Chromatograms, spectrums, or reports generated
    • Labels on samples and reagents used
  3. Confirm entries match those in the test request and batch documents.

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5.3 QA Second-Level Review

  1. Ensure that the QC review is completed and compliant.
  2. Verify critical test results (e.g., assay, dissolution, alcohol content) against specifications.
  3. Ensure OOS, OOT, or deviations are documented and investigated.
  4. Sign and date the analytical worksheet and stamp it “Approved” or “Rejected”.

5.4 Electronic Data Review

  1. Review audit trails for electronic systems (HPLC, UV, IR, etc.) to verify no unauthorized changes.
  2. Ensure electronic records are securely stored and backed up per data integrity policies.

5.5 Archival of Analytical Data

  1. After approval, all original data must be filed in the Analytical Data File specific to each batch.
  2. Electronic data must be archived in validated and access-controlled systems.
  3. Retention period: Minimum 1 year after product expiry or as per local regulations.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QC: Quality Control
  • QA: Quality Assurance
  • OOS: Out of Specification
  • OOT: Out of Trend
  • ALCOA+: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available
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7. Documents

  1. Analytical Data Review Checklist (Annexure-1)
  2. Approved Specification Sheet
  3. Test Request and Batch Record

8. References

  • 21 CFR Part 211.194 – Laboratory Records
  • ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
  • MHRA GxP Data Integrity Guidance

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Analytical Data Review Checklist

Item Checked (Yes/No) Remarks
Sample Labeling Verified Yes OK
Calculation Rechecked Yes Correct
Audit Trail Reviewed Yes No anomaly found

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial SOP Release New SOP Creation QA Head
11/04/2025 2.0 Added electronic data integrity review and ALCOA+ principles Regulatory Alignment QA Head
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