This page explains who is answerable for temperature control in each setting, what procedures and training the guidance expects, and what MHRA and CQC inspectors have actually found. The one thing to remember is that tasks can be delegated but responsibility cannot: the named person must be able to show oversight of the checks other people do.
Why it matters
Unclear roles are where checks go missing
Temperature control rarely fails because nobody cares. It fails because everyone assumes someone else did the reading, or because the one person who knew how to reset the thermometer was on leave. The NHS England South West ICARS toolkit lists unclear roles and missed checks during staff absence among its avoidable cold chain breaches, which is why naming deputies and setting up cross-cover is part of the expectation rather than an extra.
Responsibility also decides who makes the hard call after an excursion. UKHSA's incident guidance says the provider where the breach happened decides whether vaccines can still be used, after specialist advice, and takes responsibility if they are used. A decision like that needs a named person and documented reasoning.
What the rules say
Wholesale: the Responsible Person
Regulation 43 of the Human Medicines Regulations 2012 requires a licence holder to have a quality system setting out responsibilities, processes and risk management. MHRA Guidance Note 6 sets out the Responsible Person's role: at least one year's practical experience of the licensed activities, the technical knowledge to understand storage conditions and temperature control, continuous contactability and UK residence. Regulation 45 requires every licence holder to have a Responsible Person with adequate knowledge and experience, whose functions include ensuring product quality is maintained in line with the marketing authorisations, and EU GDP 2.2 adds that the RP "may delegate duties but not responsibilities". GN6 also says 'Deputy RP' is not a legally recognised term, so the named RP carries legal responsibility for delegated tasks such as daily temperature checks, receives written reports on them and keeps records showing oversight.
The MHRA Inspectorate's mapping blog adds that the RP should be involved in mapping, supervise routine daily min/max monitoring and be consulted on any excursion. In Ireland the HPRA sets a different experience minimum; see the MHRA and HPRA comparison.
Practices, pharmacies, wards and care homes
Green Book chapter 3 asks for at least two named people, one from nursing and one from administration or management, responsible for ordering, receipt, cold chain recording, stock rotation and disposal. They may delegate monitoring, but only to staff who understand the whole process. CQC's GP mythbuster 17 repeats the two trained, designated staff and expects a cold chain policy covering delivery to administration, transport, breaches and shared learning.
NHS SPS says every organisation that stores medicines should have a local temperature control policy covering responsibility and accountability, monitoring, maintenance, excursions and contingency. It names the regulators: the GPhC for registered pharmacies, CQC for hospitals, GP practices and care homes, and the MHRA for specials and wholesale licence holders. For care homes, NICE SC1 asks for a process that covers storage temperatures and how they are monitored. The community pharmacy vaccination specification requires SOPs covering cold chain, escalation, record-keeping and training, reviewed regularly and after any significant incident.
- Responsible PersonWholesale dealer
- Legally responsible, including for delegated checks
- Receives written reports on delegated duties
- Supervises daily min/max monitoring
- Consulted on every excursion
- Two named vaccine leadsGP practice
- One from nursing, one from admin or management
- Cold chain records, rotation and disposal
- Delegates only to trained staff
- Set by local policyWards and clinical areas
- Clear lines for checking, recording and reporting
- Out-of-limit results reported to the right person
- Medicines assessed before continued use
- Registered providerCare home
- A process for storage temperatures and monitoring
- Staff trained to read, reset and act
- A route to escalate storage concerns
Drawn from GN6, the Green Book, CQC, NICE SC1 and the 2015 NHS Pharmaceutical QA Committee guidance.
What good looks like
Named, trained, covered and reviewed
Name the lead and a deputy in your procedure, and make sure both are trained and assessed as competent, as UKHSA expects of everyone who orders, stores or handles vaccines. Write a short SOP for the daily checks, alarms and excursions, and review it on a set cycle (Public Health Scotland suggests every two years) and after every significant incident.
Build oversight into the routine: the lead reviews and signs the records, and the review itself is recorded. The SW ICARS toolkit recommends a quarterly vaccine management review. If a third party monitors your fridges, remember the VMD's point that this does not transfer responsibility for responding to alerts.
Worked example
The vaccine lead goes on leave
This is an illustrative example. A practice's lead nurse for vaccines is away for two weeks. Before she goes, the administrative lead, the second named person, confirms that two healthcare assistants are trained to read, record, reset and react, and the rota names who reads the fridge each morning and who checks it was done.
On day six a reading is out of range. The assistant records it, quarantines the stock and calls the administrative lead, who follows the SOP and contacts the screening and immunisation team. When the nurse returns she reviews the fortnight's records, signs the review and adds the incident to the next quarterly review. Every step is written down, so the practice can show an inspector who did what.
Where it's unclear
Where the sources leave it to you
RP experience differs between the MHRA and the HPRA (one year or six months). No national source names a specific role on hospital wards: the 2015 NHS Pharmaceutical QA Committee guidance asks only for clear lines of responsibility, and SPS and the RPS leave it to local policy. Who checks at weekends is also left open (weekends and closed periods). Where the guidance is silent, assess the risk, name the person in your procedure and record your reasoning.
Inspection findings
What MHRA, CQC and GPhC inspectors have found
The MHRA GDP deficiency data for 2016, a sample of 148 of 1,428 inspections, cites major deficiencies including mapping that did not show where to place thermometers, cold chain deviations recorded but not put through CAPA, an RP who admitted fabricating readings to fill gaps, missing transport contracts, no audits of contract acceptors and 'customer collects' arrangements never formalised. GN6 gives storage of refrigerated products at ambient temperature as a possible critical deficiency. At manufacturers, the 2015 GMP deficiency examples include contractor mapping the company had not approved.
CQC publishes expectations rather than deficiency data: mythbuster 17 says inspectors may ask for the fridge log, maintenance checks and the breach policy, and may look in the fridge. PHE's Q&A on CQC inspection covers what to do when an inspector finds gaps in fridge records. GPhC inspection reports show the same pattern: one published in 2026 records standard 4.3 as not met because a pharmacy recorded temperatures for only one of its two fridges, and the unrecorded one showed an out-of-range maximum. See monitoring and alarms and records and data integrity for the detail behind these findings.
In summary
The short version
- Name a lead and a deputy for temperature control, in writing.
- In wholesale, the RP stays legally responsible for delegated checks and must show oversight.
- Delegate only to staff trained to read, record, reset and react.
- Keep a local temperature control policy and SOPs, reviewed regularly and after incidents.
- Record your reviews, not just your readings.
- Plan cover for leave, weekends and closures.
- Expect inspectors to ask for the log, the maintenance records and the breach policy.