What an inspection checklist is and why it matters
An inspection checklist is a list of control questions whose answers show whether an organization complies with mandatory requirements. Roszdravnadzor Order No. 5803 approved forms for the various areas of federal control over the circulation of medicinal products: storage, dispensing and sale, destruction, compounding, prices of drugs on the Vital and Essential Drugs List, licensing requirements, and studies. Each question refers to a specific clause of a regulation, so preparation comes down to a simple rule: for every question you need a document or record that you can show.
The checklist is useful even without an inspection: it is a convenient basis for an internal audit of the quality system, which the Storage Rules (Order No. 260n) require anyway when violations occur.
Self-check: 18 temperature questions
Structure of the storage section
The questions of the storage checklist can be grouped into thematic blocks. For temperature conditions, the key ones are equipment, temperature and humidity control, computerized systems, and receipt.
| Block | What is asked | Relevance to temperature |
|---|---|---|
| Quality system | SOPs, responsible persons, internal audits, corrective actions | SOP for monitoring storage conditions and for actions in case of deviations |
| Personnel | appointment of responsible persons, training | who is authorized to perform temperature control |
| Premises and zones | functional zones, floor area, segregation | zones with special storage conditions |
| Equipment | air conditioning, refrigerators, alarms, access control system, measuring instruments | availability and verification of measuring instruments, refrigeration equipment |
| Temperature and humidity control | daily control, logbook, placement of monitoring devices, mapping | the core block |
| Computerized systems | use and validation of systems | electronic logbook and monitoring system |
| Expiry dates | tracking of products with limited shelf life | — |
| Receipt | conformity checks, conditions during transportation | checking temperature conditions during delivery |
| Special groups | substances subject to quantitative accounting, flammable, thermolabile products, etc. | storage of thermolabile medicinal products |
Temperature questions and what to show
Below is the substance of the questions that follow from the current requirements, together with the evidence worth keeping at hand. Check the exact wording against the text of the order.
| Essence of the question | Requirement | What to show |
|---|---|---|
| Do storage conditions match those specified by the manufacturer and the pharmacopoeia; in the absence of instructions, +15…+25 °C and RH ≤ 65 %? | 260n, clause 17 | logbook or monitoring system report for the period, conditions by zone |
| Are temperature and humidity checked daily, including weekends and public holidays, and recorded in a logbook? | 260n, clause 18 | a logbook with no gaps or an electronic archive with a report for any dates |
| Are verified measuring instruments or an automated monitoring system used? | 260n, clauses 11, 18 | list of measuring instruments with serial numbers and verification records in FSIS Arshin |
| Has temperature mapping been performed (for a wholesale organization)? | 260n, clause 18; EAEU GDP, clause 39 | mapping protocol and report for each zone, with summer and winter studies |
| Are monitoring devices placed at the points of greatest fluctuation, based on the mapping results? | 260n, clause 18 | sensor layout and its link to the hot and cold spots identified in the report |
| Is mapping repeated based on risk analysis and after changes to premises or equipment? | 260n, clause 18 | risk assessment, decision on re-mapping, reports after layout changes |
| Is compliance with storage conditions during transportation checked on receipt? | 260n, clause 25 | carrier's data logger printouts, temperature indicator readings, notes in receiving documents |
| Are computerized systems validated? | 260n, clause 10; EAEU GDP | monitoring system validation report, change log |
| Are thermolabile medicinal products stored in cold rooms or refrigerators? | 260n, clause 45 | list of equipment, temperature logs for the inside of refrigerators |
| Have SOPs been developed and are corrective actions taken when violations occur? | 260n, clauses 2–3 | SOPs, deviation records, CAPA |
Typical nonconformities
- gaps in the logbook for weekends and public holidays;
- the thermohygrometer's verification has expired, and nobody has checked its record in Arshin;
- the sensor is installed “wherever convenient” rather than based on the mapping results;
- a single mapping report covers all seasons or was produced with unverified instruments;
- SOPs refer to the repealed Orders No. 646n and No. 706n;
- deviations are recorded, but there is no investigation and no corrective action;
- an electronic system is in use, but there are no documents on its validation.
How a monitoring system helps during an inspection
| Inspector's request | How the Hladverk Group system responds |
|---|---|
| Temperature log for an arbitrary period | the report is generated in a minute, with no gaps for weekends |
| Deviations and what was done about them | a list of events with acknowledgment, comments and CAPA |
| Instrument verification | maintenance log with serial numbers and verification dates |
| Justification of monitoring points | a mimic diagram showing the points, with a reference to the mapping report |
| Data integrity | audit trail and validation documents |
Frequently asked questions
When do the new inspection checklists take effect?
Roszdravnadzor Order No. 5803 of 2 December 2025 entered into force on 21 March 2026.
Is mapping checked at pharmacies?
According to industry reviews, the mapping questions are addressed to wholesale organizations. At pharmacies, inspectors check daily temperature and humidity control and the keeping of logbooks.
Can I show the inspector an electronic logbook?
Yes. The Rules approved by Order No. 260n allow electronic records with archiving. Be ready to show the system validation documents as well.
What happens if mapping has not been performed?
For a wholesale organization this is a violation of the storage rules; if it is classified as a gross violation of licensing requirements, it can result in a fine under Part 4 of Article 14.1 of the Russian Code of Administrative Offenses or suspension of operations.