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Polymetrica/Compliance/GDP and MHRA

GDP and MHRA: mapped, monitored, and still provable a year later

Good Distribution Practice for medicinal products asks for storage areas that have been mapped, monitored continuously, with excursions that reached a person and a record that survives the inspection. All four come out of the same system.

Request a facility review What we measure
mappedpoints placed from a mapping exercise
continuousmonitoring between qualification runs
alarm trailwho was reached, and when
Validation reporting: hourly values with deviations from the limits
What is expected

What GDP expects, and where the data comes from

The obligations cluster around four things: knowing the temperature profile of a storage area, watching it continuously, reacting to excursions, and being able to show all of it afterwards.

Temperature mappingThe profile of a storage area, with the point positions and the findings recorded.
Points placed from the mappingSensors sited where the mapping found the extremes, not where a cable happened to reach.
Continuous monitoringReadings per point at a fixed interval, with the permitted range stored alongside them.
Excursion handlingStart, duration, return to range, and the alert trail behind it.
HumidityWhere the product specification sets a humidity range as well as a temperature one.
Backup powerThe record continues through a power cut, so there is no gap to explain.
ExportValidation-format reports in XLS and PDF, for any period.

We provide monitoring, mapping data and reports. We are not a qualification consultancy, we do not write your validation protocols, and nothing here makes a facility GDP compliant: your Responsible Person and your inspector decide that. What we provide is the evidence they ask to see.

An excursion you cannot explain is an excursion you cannot close

Start with the storage areas that carry the tightest range.

Request a facility review
Requirement and response

What is expected, and what you hand over

What is expected
What the system provides
What you hand over
The storage area has to be mapped
Mapping data with the point positions and the profile recorded
A mapping report
Monitoring has to be continuous
Readings per point at a fixed interval, with no manual entry
An unbroken record
An excursion happens overnight
The alert reaches the responsible person and the event is logged with its duration
An event with a decision behind it
The inspector asks for last year
Any period exports in validation format
A report, rather than a reconstruction
Proof

Screens from live facilities

Validation reporting: hourly values with deviations from the limitsMapping
Temperature report: every control point in the facility over 24 hoursReporting
Already running at
2 pharmaceutical manufacturers plasma-derived medicines manufacturer clinical laboratory network blood transfusion centre

Deployments to date are largely in Ukraine.

Rollout

From pilot to full coverage

STEP 1

Facility review

We look at what is installed, which parameters are critical and where the losses are today.

At your facility or remote
STEP 2

Pilot on 5-10 points

A gateway, sensors and meters on the riskiest zones. Installed without stopping operations.

A few hours per facility
STEP 3

Dashboards and reports

We draw up the facility plan, set the limits for each point, the alerts and the report formats.

Shaped around your processes
STEP 4

Scaling up

The same kit across the remaining zones and facilities, with a single view for the whole company.

No new approvals needed
Next step

We will show you the mapping and the report format

Send us your storage areas and the range each one has to hold. We will propose where the points go and prepare a sample report.

Request a facility review

Just a few lines is enough. We will prepare a preliminary estimate and an equipment list before we talk.

Name and contact are required. Everything else is optional.

Your name, then a comma, then your company. For example: Maria Santos, Acme Foods

An email address such as name@company.com. Or a phone number with the country code, starting with a plus sign, for example +44 20 7123 4567 or +49 30 1234 5678.

Where the facility is, which may not be where you are. It tells us which rules apply and who picks the enquiry up.

For example: 4 storage areas, mapping for two cold rooms, validation-format reports

We reply within one business day. We never share your details.

If the security check does not load, or you would rather not use this form, email us at sales@polymetrica.net - it reaches the same team.

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IndustryPharmaceuticalsstorage conditions and audits SolutionCold chain monitoringrooms, docks, dispatch CapabilityReports and compliancerecords, mapping, audits