samples tested in the QC laboratory of the API manufacturing unit.

3. Responsibilities

• QC Analyst: Generate complete analytical reports based on approved test procedures and record raw data.
• QC Reviewer: Review the report for accuracy, calculations, compliance with specifications, and proper documentation.
• QA Officer: Verify and approve finalized reports and assess any deviations or discrepancies.

4. Accountability

The Head – Quality Control is accountable for the completeness, correctness, and regulatory compliance of all analytical test reports and their timely review and approval.

5. Procedure

5.1 Preliminary Verification

1. Ensure that the analytical report is printed or documented using the correct template as per SOP format.
2. Verify sample details:
   • Sample ID and batch number
   • Sample quantity and container condition
   • Date of receipt and testing
3. Ensure use of correct and current specifications and STP number.

5.2 Review of Raw Data and Calculations

1. Cross-verify all raw data including instrument printouts, balance readings, titration volumes, chromatograms, and observation logs.
2. Check calculations for accuracy. Use calculator or spreadsheet validation if needed.
3. Ensure significant figures and rounding rules are applied consistently across all tests.

5.3 Review of Results and Compliance

1. Ensure that results are:
   • Within specification limits
   • Consistent with batch trend (if applicable)
   • Reported clearly in units defined in the STP/specification
2. For OOS/OOT results, ensure that an investigation reference is documented and attached.

5.4 Verification of Signatures and Approvals

1. Ensure that:
   • All pages are signed and dated by the analyst
   • Reviewer’s name, date, and signature are present on each test section
   • Final approval is signed by the QA and/or QC Head
2. If any page is missing or incorrect, send back to the analyst for correction and re-verification.

5.5 Archival of Reports

1. Once approved, compile the analytical report along with supporting documents.
2. Hand over to document control for secure archival as per the document retention policy.
3. Ensure traceability by updating the Analytical Report Index Register (Annexure-1).

6. Abbreviations

• STP: Standard Test Procedure
• QA: Quality Assurance
• QC: Quality Control
• OOS: Out of Specification
• OOT: Out of Trend
• SOP: Standard Operating Procedure

7. Documents

1. Analytical Test Report Template
2. Raw Data Sheets
3. OOS/OOT Investigation Reports
4. Analytical Report Index Register (Annexure-1)

8. References

• ICH Q7 – GMP for APIs
• 21 CFR Part 211 – Current Good Manufacturing Practice
• MHRA Guidance on Data Integrity

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 Report Index Register

Report No.	Batch No.	Sample ID	Prepared By	Reviewed By	Approved Date
AR-20250413-001	API-20250413	SMP-001	Sunita Reddy	Rajesh Sharma	13/04/2025

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Release	GMP Requirement	QA Head
13/04/2025	2.0	Included Checklist and Raw Data Review Emphasis	Audit Finding	QA Head