Verify Strip Pack Leak Test Results During Every GMP Shift

Do Verify Strip Pack Leak Test Results During Every GMP Shift

Remember: Always perform and document strip pack leak tests at every shift — packaging integrity is critical for maintaining drug stability and compliance.

Why This Matters in GMP

Strip packs are commonly used to package tablets or capsules. These packs must remain hermetically sealed to protect products from environmental factors such as moisture, air, and contaminants. Performing leak tests during every shift ensures that sealing machines are functioning correctly and that packs meet the required barrier properties. Failure to do so can result in compromised drug potency, microbial ingress, or product degradation.

Also Read: Check Airlock Manometer Calibration in GMP Facilities for Pressure Control

For example, a minor misalignment in the sealing jaws may result in micro-leaks that aren’t visible but allow moisture ingress. If not detected promptly, hundreds of defective packs may reach the market, leading to customer complaints, product recalls, and regulatory consequences.

Regulatory and Compliance Implications

21 CFR Part 211.130 requires in-process inspection of packaging and labeling operations. EU GMP Annex 15 emphasizes the need for qualification of packaging processes and periodic in-process checks. WHO GMP recommends routine testing of strip and blister packaging integrity during production to ensure continued suitability.

Auditors expect documented

evidence of leak test frequency, results, methods used, and actions taken on failures. Lack of routine leak testing or improper documentation may lead to findings under packaging control deficiencies and quality oversight lapses.

Also Read: Never Use Unlabeled Syringes in GMP Quality Control Laboratories

Implementation Best Practices

Use validated leak testing methods such as vacuum decay, dye ingress, or pressure differential. Define leak test frequency in SOPs — typically per shift or per batch hour. Ensure that results are logged, reviewed by QA, and linked to product release documentation.

Train operators on identifying seal quality defects, setting machine parameters, and responding to test failures. Calibrate and maintain leak testing equipment as per manufacturer guidelines. Include trend analysis of failure rates in product quality reviews.

Regulatory References

– 21 CFR Part 211.130 – Packaging and labeling control
– EU GMP Annex 15 – Qualification and validation
– WHO TRS 961, Annex 9 – Packaging integrity testing
– USP – Packaging Integrity Evaluation

Also Read: Document All OOS Investigations Within Prescribed GMP Timelines