GDP, GMP & Revised Schedule M Temperature and Humidity Monitoring

Inspectors read the SOP first and then check that the site follows it. A pharma warehouse temperature and humidity SOP that survives an audit usually covers the following. Ideabytes can share a template SOP on request that you adapt to your site and approve through your own document control.

Revised Schedule M, notified by the Ministry of Health and Family Welfare in December 2023, brings India's GMP rules closer to WHO GMP. It introduces a pharmaceutical quality system, quality risk management, qualification of equipment and utilities, and validation of computerised systems. Compliance dates were phased for larger manufacturers and for MSMEs, as notified; check the latest notification for the date that applies to your licence.

For storage areas the practical effect is clear. Warehouses and stores must be qualified, storage conditions must be monitored with calibrated instruments, records must be reliable and reviewable, and any computerised monitoring system must be validated. A manual register filled twice a day is increasingly hard to defend under these expectations.

WHO good storage and distribution practices and the EU GDP guidelines set similar expectations for anyone who holds or moves medicines. Storage areas are mapped before use, monitoring devices sit where mapping shows the extremes, devices are calibrated at defined intervals, alarms warn of excursions in time to act, and records are kept and reviewed. Transport routes and vehicles are qualified too, with monitoring during transit where products are temperature-sensitive.

EU GMP Annex 15 adds the qualification and validation framework behind mapping and monitoring systems. Indian exporters to regulated markets meet all three sets of expectations, so a single SOP written to the strictest of them is usually the most efficient approach.

Manual logs record two moments a day and miss everything between them: the night-time chiller trip, the weekend power cut, the dock door left open during unloading. They invite transcription errors and back-filled entries, and they cannot raise an alarm. Continuous monitoring closes each of these gaps.

Ideabytes loggers record at a configurable interval, 15 minutes by default, and send live alerts and app push notifications, with optional SMS, when a limit is crossed. Scheduled daily, weekly or monthly reports arrive without anyone compiling them, and the platform calculates MKT for temperature, which is the value an excursion impact assessment relies on. Audit trail, alarm logs and CAPA records sit alongside the data.

Set two levels. Alert limits sit inside the labelled range and warn staff that conditions are drifting, so they can act before product is at risk. Action limits match the labelled range and trigger the excursion procedure. Add a short alarm delay where door openings cause brief spikes, and justify it in the SOP rather than widening the limits.

Name who receives each alarm, by shift, and who is next if nobody acknowledges within a set time. When an excursion occurs, record its start, end, peak value and duration, quarantine affected stock, and assess the impact using MKT and the manufacturer's stability data before release. Close the loop with a deviation and, where the cause is systemic, a CAPA.

Choose connectivity by site. Wi-Fi models such as the WTH120 suit warehouses with managed Wi-Fi; 4G M2M models such as the MTH120 carry a built-in SIM for sites where IT will not allow devices on the network; Ethernet models such as the ETH120 fit plants with wired IT policies; and offline loggers such as the OTH120 record on board for download over Wi-Fi or USB.

The temperature and humidity models are rated -40 to +120 °C and 0 to 100 % RH, with accuracy of ±0.5 °C (from -10 to +50 °C) and ±2 % RH. For cold rooms and stability chambers with many points, the 8-channel PT100 loggers MTR8 and WTR8 monitor eight probes from one unit, and the MT350 PT100 logger covers freezers and ultra-low units. NABL-traceable calibration certificates are available on request for each logger.