and approval of test results within the API manufacturing facility. It includes manual entries, instrument printouts, electronic records, and analytical worksheets.

3. Responsibilities

• QC Analyst: Accurately record test results, observations, and calculations in the approved format.
• QC Reviewer: Verify correctness of data, calculations, and compliance with specifications.
• QA Officer: Review completed records for completeness and adherence to data integrity principles.

4. Accountability

The QC Head is accountable for ensuring proper documentation practices and review controls are followed, in alignment with GMP and regulatory expectations.

5. Procedure

5.1 Documentation of Test Results

1. Use blue or black permanent ink for manual entries. Corrections should be made by striking through the error with a single line, initialing, and writing the correct entry alongside.
2. Document results in approved QC worksheets or logbooks immediately after test completion.
3. Each result entry must be traceable to:
   • Sample ID / batch number
   • Test method / STP number
   • Instrument ID (if applicable)
   • Analyst initials and date
4. Attach relevant instrument printouts (chromatograms, pH meter printouts, etc.) with sample ID and analyst signature.

5.2 Review of Results

1. All results must be reviewed by a qualified reviewer who was not involved in performing the test.
2. Ensure:
   • Calculations are correct
   • Values fall within the specification limits
   • Raw data matches reported values
   • Any OOS/OOT is clearly documented and investigated
3. Sign and date all reviewed pages with comments, if applicable.

5.3 Out-of-Specification (OOS) and Out-of-Trend (OOT) Handling

1. OOS or OOT observations must be recorded in the data sheet and immediately notified to QA.
2. Initiate the investigation as per the OOS/OOT SOP and attach a reference copy with the analytical report.
3. Do not alter or overwrite original entries or results.

5.4 Approval and Archiving

1. After review, QC Head or designee must approve the final analytical report with date and signature.
2. Transfer completed and reviewed analytical records to the document control department for archival.
3. Retain records for a minimum of 5 years post batch expiry or as per regulatory requirements.

5.5 Data Integrity Practices

1. Follow ALCOA+ principles:
   • Attributable
   • Legible
   • Contemporaneous
   • Original
   • Accurate
   • Complete, Consistent, Enduring, and Available
2. Avoid use of pencils, correction fluid, or unapproved abbreviations.
3. Ensure all electronic data is backed up, secure, and access-controlled.

6. Abbreviations

• QC: Quality Control
• QA: Quality Assurance
• GMP: Good Manufacturing Practice
• OOS: Out of Specification
• OOT: Out of Trend
• STP: Standard Test Procedure
• ALCOA: Attributable, Legible, Contemporaneous, Original, Accurate

7. Documents

1. QC Analytical Worksheet (Annexure-1)
2. Instrument Printout Attachment Log
3. OOS/OOT Investigation Form

8. References

• ICH Q7 – GMP for APIs
• 21 CFR Part 211 – US FDA
• MHRA Data Integrity Guidance
• WHO TRS 996 – Annex 5

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: QC Analytical Worksheet

Test	Result	Specification	Instrument ID	Analyst	Date
Assay	99.2%	98.5–101.5%	HPLC-03	Sunita Reddy	13/04/2025

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	GMP Compliance	QA Head
13/04/2025	2.0	Added ALCOA+ and archival controls	Audit Observation	QA Head