Reviewing and retaining monitoring records
A monitoring record nobody reviews is not a control. Define the review frequency, what the reviewer checks, how the review is recorded, and how long records are kept.
GDP requires temperature records to be reviewed and retained. Review turns data into evidence: someone competent looked, checked against limits, noticed gaps and drift, and signed. Retention makes the evidence available to later investigations and inspections.
A review checklist
- All sensors reporting; no unexplained gaps.
- All values within alert limits; excursions matched to deviation records.
- No sensor flat-lining, stuck values or implausible steps.
- Calibration due dates not passed.
- Alarm log reviewed; acknowledgements and responses present.
- Reviewer name, date and conclusion recorded.
Retention
Retention periods are set by the applicable regulation and company policy; for medicinal products they typically extend at least one year past product expiry, and often five years or more. Records must remain readable — a proprietary export format with no viewer is not 'available'.
Frequently asked questions
- Does the review have to be by quality personnel?
- The reviewer must be competent and independent enough from the operation to be credible; quality oversight of the process is expected, but day-to-day review can be delegated with training.
References
- [1]EU Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01)
- [2]PIC/S PI 041-1: Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (2021)
General technical guidance written against the cited sources. It is not regulatory or legal advice and does not replace the applicable standard, guideline or a qualified reviewer's judgement.
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