GMP and regulatory standards. The QC Supervisor is responsible for ensuring accurate data collection and report preparation.

5. Procedure

5.1 Pre-Report Preparation

Before preparing the QC report, ensure the following:

1. Review Test Results
   1. Ensure that all required tests (e.g., hardness, disintegration, fill volume, etc.) have been completed and documented for the relevant batch of capsules.
2. Ensure Data Completeness
   1. Check that all test data is complete and accurate. All sample results must be recorded, including any deviations or failures in the test procedures.
3. Prepare Testing Equipment Logs
   1. Verify that equipment calibration logs and maintenance records for testing equipment are up to date.

5.2 Report Compilation

Follow these steps to compile the QC report:

1. Document Test Data
   1. Document the results for all tests performed on the batch, including capsule weight, hardness, disintegration time, fill volume, etc. Include the acceptance criteria for each test.
2. Identify Deviations
   1. If any test results deviate from the specified acceptance criteria, note the deviation and any corrective actions taken.
3. Provide Conclusions
   1. State the conclusions regarding the quality of the batch based on the test results. If the batch passes all tests, state that the batch is approved for further processing. If there are any failures, state the corrective actions taken or required.
4. Prepare Summary
   1. Provide a summary of the testing process, including the number of capsules tested, the testing methods used, and any issues encountered during testing.

5.3 Post-Report Review

After the QC report is compiled, ensure the following:

1. Review by QA
   1. The QA team reviews the QC report for accuracy, completeness, and compliance with regulatory requirements. Any discrepancies or issues should be resolved before final approval.
2. Approval and Signature
   1. Once reviewed and approved, the QA team signs off on the report. The signed report is then stored for future reference.
3. Distribution
   1. The final QC report is distributed to the appropriate departments (e.g., production, regulatory affairs) and stored in the relevant batch records.
4. Record Keeping
   1. Ensure that all completed QC reports are properly filed and archived in accordance with GMP and regulatory guidelines for future reference or audits.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• EP: European Pharmacopoeia
• USP: United States Pharmacopeia

7. Documents

1. Annexure 1: QC Test Data Log
2. Annexure 2: Corrective Action Report
3. Annexure 3: Batch Approval Form

8. References

• USP <701> – Disintegration of Tablets and Capsules
• European Pharmacopoeia 2.9.1 – Dissolution Testing
• Good Manufacturing Practice (GMP) Guidelines

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 Test Data Log

Batch ID	Test Date	Test Type	Test Results	Comments
Batch 014	02/02/2025	Hardness	8.2 N	Pass

Annexure 2: Corrective Action Report

Batch ID	Deviation	Corrective Action	Responsible Person	Completion Date
Batch 014	Low fill volume	Adjusted filling machine settings	Production Supervisor	03/02/2025

Annexure 3: Batch Approval Form

Batch ID	Approval Status	Approved By	Approval Date
Batch 014	Approved	QA Manager	05/02/2025

12. Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial version of SOP	Creation of SOP for QC reporting	QA Head
01/02/2025	2.0	Updated report format and test procedures	Improvement of reporting process	QA Head