Verify Integrity of Tamper-Evident Seals During Packaging

Check Tamper-Evident Seals for Integrity During Packaging

Remember: Tamper-evident seals must be visually verified during packaging to ensure they are applied correctly and uncompromised.

Why This Matters in GMP

Tamper-evident packaging is a vital mechanism for protecting pharmaceutical products against manipulation and counterfeiting. These seals serve as visible assurance that a product is intact and has not been opened or altered after manufacturing. If seals are damaged, improperly applied, or missing, it compromises the credibility and security of the product. Patients may receive adulterated medicines, leading to potential health risks and loss of consumer trust. Verifying seal integrity ensures product authenticity and supports product traceability. This verification is especially important during packaging line clearance, batch release, and market complaints investigations.

Also Read: Label In-Process Samples with Date and Initials for Traceability

Regulatory and Compliance Implications

FDA 21 CFR Part 211.130 and 211.132 require packaging controls and tamper-evident features for consumer safety. WHO GMP and Schedule M require physical integrity checks of packaging materials during production. EU GMP expects inspection procedures and traceability of packaging components. Missing or compromised seals are considered critical quality defects and may lead to recalls or regulatory sanctions. QA must establish procedures for inspecting and documenting seal integrity, especially on primary and secondary packaging lines. Packaging records should clearly indicate the type, application method, and inspection outcome for each batch.

Implementation Best Practices

Train packaging operators to visually inspect every tamper-evident seal during the packaging process.
Use automated camera systems for seal presence and position verification where feasible.
Include seal integrity checks in packaging SOPs and in-process quality assurance protocols.
Document seal inspections with batch number, line operator initials, and time stamps.
Maintain records of seal lot numbers and suppliers in batch records for traceability.

Also Read: Update GMP Training Records After Every Training Session

Regulatory References

FDA 21 CFR Part 211.130 – Packaging and Labeling Operations
FDA 21 CFR Part 211.132 – Tamper-Evident Packaging for OTC Human Drug Products
EU GMP – Chapter 5 and Annex 15
WHO GMP – Packaging Practices
Schedule M – Labeling and Packaging Control