What are the GDP monitoring requirements for temperature-sensitive medicines?

GDP requires continuous monitoring of time- and temperature-sensitive medicines during storage and distribution. Devices must be qualified, calibrated, and placed according to temperature mapping results. Records must be secure, retrievable, and available for audits.

Core monitoring requirements:

• Use calibrated devices with ISO 17025 traceability and valid certificates.
• Place sensors at hot and cold spots identified during temperature mapping studies.
• Configure alarms and escalation linked to predefined acceptance criteria.
• Ensure continuous recording with validated data integrity controls.

Inspector insight: Inspectors often check whether monitoring placement is documented in the monitoring plan and directly linked to the mapping report.

Also read: GDP temperature mapping: Protocols, frequency, and acceptance criteria

How do Annex 11 and 21 CFR Part 11 apply to GDP monitoring systems?

Electronic monitoring systems used under GDP must comply with Annex 11 and 21 CFR Part 11. Both frameworks focus on ensuring data integrity, traceability, and secure management of electronic records. To meet these expectations, systems must restrict access through role-based permissions, automatically log every change with a time-stamped audit trail, and use electronic signatures for approvals, such as deviation handling and reporting. Records must also be archived securely so they remain tamper-proof and retrievable in full during inspections.

Inspector insight: A common finding is missing or incomplete audit trails. Regulators expect validated audit trail functionality in monitoring systems, along with SOPs that define how these records are reviewed.

Also read: 21 CFR Part 11 explained

How should alarms be set up under GDP monitoring requirements?

Alarms are essential for a timely response to deviations. GDP requires alarms to be risk-based, clearly defined, and linked to SOPs for investigation and escalation.

Best practice for alarm setup:

• Set thresholds from acceptance criteria: Use mapping results and product ranges to define alarm points.
• Reduce false alarms: Apply short delays or deadbands to filter harmless fluctuations.
• Define escalation paths: SOPs must state who receives alarms, who investigates, and how CAPA is assigned.
• Document ownership: The RP or QA manager must review and approve alarm configuration.

Real-world example: A warehouse near a busy loading dock reduced nuisance alarms by applying a 10-minute delay. The change was documented in the alarm SOP and approved by the RP, preventing unnecessary investigations while maintaining compliance.

Inspector insight: Inspectors want to see that alarm settings are documented, justified, and formally approved. They often request the alarm SOP and recent deviation logs during audits.

Also read: 7 GDP compliance for pharmaceutical warehouses

How should deviations and CAPA be managed in GDP monitoring?

Monitoring is only effective if deviations trigger timely investigation and corrective action. [GDP]/gdp) requires clear SOPs for alarm response, deviation logging, and CAPA workflows. Each deviation should be logged, risk assessed, investigated, and closed with an approved CAPA when required. Documentation must show timelines, responsible persons, and sign-off by QA or the RP.

Inspector insight: Inspectors often ask: Can you show how a deviation was logged, investigated, and resolved? They expect to see CAPA records linked to alarm data and signed off by QA.

How should GDP monitoring data be documented for inspections?

GDP requires that monitoring records are secure, accurate, and accessible throughout the retention period. Data must be linked to calibration certificates and easily retrievable for inspections.

Documentation requirements:

• Link monitoring points to calibration records with certificate IDs and validity dates.
• Store data in validated systems with access controls and backup procedures.
• Ensure audit-ready reporting with trends, deviations, and CAPA records.
• Keep records accessible for the defined retention period (at least as long as product shelf life, or as required by local GDP regulators).

Inspector insight: Inspectors often ask for deviation logs showing how alarms were handled and whether CAPA was implemented. They may also request proof that calibration certificates are linked to specific monitoring devices in use.

Also read: Good distribution practice (GDP): Guidelines for pharma logistics

How can multi-site monitoring support GDP compliance?

Organizations with multiple warehouses or logistics sites face challenges with harmonization. Centralized monitoring systems allow alarm rules, escalation workflows, and reporting formats to be standardized across all sites. This improves oversight and ensures consistent responses to deviations.

Benefits of multi-site monitoring:

• Harmonized SOPs and alarm thresholds across locations.
• Enterprise dashboards for RP and QA oversight.
• Easier preparation for corporate and regulatory audits.

Inspector insight: Regulators expect central QA teams to maintain oversight of subcontracted and multi-site operations. Standardized monitoring and reporting helps demonstrate this oversight during inspections.

Also read: GDP temperature mapping: Protocols, frequency, and acceptance criteria

References and further reading

• EU GDP guideline (2013/C 343/01): Monitoring and records requirements.
• Annex 11 (EU): Electronic records and audit trails.
• 21 CFR Part 11 (US): Electronic signatures and data integrity. See also 21 CFR Part 11 explained.
• WHO TRS 961: Guidance on monitoring in storage and transport.