Do Retain Sample Sealing Tapes in Logs for Traceability and Compliance
Remember: Always retain used sample sealing tapes in the retention logs — they serve as proof of tamper resistance, traceability, and procedural integrity.
Why This Matters in GMP
Sealing tapes used on stability samples, retained samples, or quality control specimens are often tamper-evident and carry unique identifiers (e.g., batch number, color code, initials). These tapes not only secure the sample containers but also act as traceable evidence of who sealed the sample and when. Failing to log or retain tape identification details can jeopardize traceability during investigations, audits, or litigation scenarios.
For example, if a stability sample shows abnormal degradation and the container seal tape is missing or untraceable, it becomes difficult to determine whether the sample was tampered with or improperly stored. By recording tape details in retention logs, organizations protect against such data integrity gaps and demonstrate full chain-of-custody compliance.
Regulatory and Compliance Implications
21 CFR Part 211.170 mandates that retention samples be stored in a manner that protects against contamination, mix-up, and alteration. EU GMP Chapter 6 requires identification and traceability of all retained material. WHO GMP emphasizes the use of tamper-evident
Auditors examine sample storage practices, sealing integrity, and logs for tamper-evident measures. Absence of sealing tape records or inability to confirm their application may result in observations for incomplete documentation, poor sample security, or compromised chain of custody.
Implementation Best Practices
Use pre-numbered, tamper-evident sealing tapes for all GMP samples requiring retention. Record tape batch numbers, colors, sealing date, and initials of the person sealing in the sample retention log. Cross-reference with sample labels, storage location, and retention timelines.
Develop SOPs that include tape application steps, retention criteria, and log entry formats. Train QA and QC staff on sealing protocols and verification requirements. Perform periodic audits of retained samples to ensure seal integrity and matching log records.
Regulatory References
– 21 CFR Part 211.170 – Reserve sample retention
– EU GMP Chapter 6 – Quality control and sample traceability
– WHO TRS 986, Annex 4 – Sample retention and tamper prevention
– USP – Management of Retain Samples