What the document contains
- SOP “Temperature and humidity control during storage” — purpose, scope with your zones and conditions, regulations by organisation type, responsibilities, monitoring equipment, recording procedure, actions on deviation (quarantine, release decision, CAPA), equipment and emergencies, list of records.
- Temperature and humidity log — a monthly page for each zone with the permitted range in the header and a line for the verified instrument.
- Acknowledgement sheet for staff.
The document is a template. Before approval, check the conditions against the manufacturers' instructions and add your organisation's specifics. If an automated system keeps the log, the recording section already describes an electronic log with archiving.
What else you will need for an inspection
- verified measuring instruments and verification records in the FGIS “Arshin” registry — verification;
- for wholesalers — temperature mapping reports for storage zones;
- a deviation and corrective action log — CAPA;
- check yourself with the inspection self-check.
Frequently asked questions
Is it free?
Yes. We ask for your contact details so that a specialist can answer questions about the document; no mailings.
Can the document be used without changes?
It is a good basis, but the SOP is approved by the head of the organisation — check the conditions, responsible persons and record retention, and add the number and date.
Can the log be kept electronically?
Yes, Rules No. 260n allow an electronic log with archiving. Choose “Automated monitoring system” and the SOP will describe that procedure.