Team: Responsible for reviewing and approving the packaging integrity test results to ensure compliance with regulatory and internal specifications.

4. Accountability

The QC Manager is accountable for ensuring that packaging integrity testing is carried out accurately and in accordance with this SOP. The Production Supervisor is responsible for ensuring that the products are properly filled and sealed. The QA Manager ensures the integrity and compliance of packaging tests with regulatory requirements.

5. Procedure

5.1 Pre-Test Preparation

1. Ensure that all necessary equipment for packaging integrity testing is available, including a vacuum tester, pressure tester, and leak detection equipment, if applicable.
2. Calibrate testing equipment according to the manufacturer’s instructions to ensure accurate test results.
3. Review the batch record to identify the appropriate sample sizes and the packaging materials used for the cream products.

5.2 Sample Collection

1. Collect a representative sample of finished cream products from the production line after packaging. Ensure that the sample includes different packaging types (e.g., tubes, jars, and bottles) to test a variety of packaging formats.
2. Label each sample with the batch number, packaging type, sampling date, and sampling point to ensure traceability during testing.
3. Ensure that the samples are taken from sealed, finished products ready for shipment.

5.3 Packaging Integrity Testing Procedure

1. Conduct the following tests to evaluate the integrity of the packaging:
   • Vacuum Test: Use a vacuum chamber to test the integrity of the seals and closures. Place the product inside the chamber and apply a vacuum. Check for any loss of vacuum, indicating a seal failure.
   • Pressure Test: Subject the packaging to controlled internal pressure. Monitor for any leakage or deformation that could compromise the integrity of the container.
   • Leak Detection Test: Use a leak detection system (e.g., water immersion or helium leak detector) to identify any cracks or holes in the packaging that could lead to contamination or loss of product.
   • Seal Strength Test: Measure the force required to break or tear the seal on packaging to ensure that it meets the required specifications.
2. Record the results of each test, noting any deviations or failures in packaging integrity.

5.4 Interpretation of Results

1. Compare the test results with the specified packaging integrity criteria. Packaging must meet the predefined standards for vacuum, pressure, and leak resistance.
2. If the packaging integrity fails any of the tests (e.g., leakage, seal failure), mark the test result as “Fail” and investigate the cause of the failure.
3. If the packaging passes all tests, mark the result as “Pass” in the Packaging Integrity Testing Log (Annexure-1) and proceed with the next stage of production or distribution.

5.5 Post-Test Activities

1. Record the results of all tests, including batch number, sample ID, test type, test conditions, and results, in the Packaging Integrity Testing Log (Annexure-1).
2. If packaging integrity fails, initiate corrective actions such as reviewing sealing processes, improving packaging material quality, or adjusting machine settings. Re-test the sample after corrective actions.
3. Submit the test results for review and approval by the QA team to ensure compliance with internal and regulatory packaging standards.

5.6 Documentation and Record-Keeping

1. Ensure that all packaging integrity testing records are complete, accurate, and securely stored. This includes the Packaging Integrity Testing Log (Annexure-1) and the Deviation Log (Annexure-2) for failed tests.
2. Retain all records for a minimum of two years or as required by regulatory guidelines.
3. Ensure that records are reviewed and approved by the Quality Assurance team to verify compliance with GMP standards and regulatory requirements.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QC: Quality Control
• QA: Quality Assurance
• PPE: Personal Protective Equipment

7. Documents

1. Annexure-1: Packaging Integrity Testing Log
2. Annexure-2: Deviation Log

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• Pharmacopeial Monographs for Packaging Integrity Testing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Packaging Integrity Testing Log

Batch Number	Sample ID	Test Date	Test Type	Test Result	Operator
12345	S-001	21/01/2026	Vacuum Test	Pass	John Doe

Annexure-2: Deviation Log

Deviation Date	Batch Number	Deviation Description	Corrective Action Taken	Operator
21/01/2026	12345	Leak detected in packaging	Re-sealed packaging, re-tested	Jane Smith

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head