Regulatory quality for the transportation of medicines and medical devices

Intelilab assesses controls related to carriers, routes, vehicles, environmental conditions, occurrences, traceability and cold chain where applicable.

Where risks arise in transportation

A delivery can arrive on time and still leave doubts about the conditions in which the product traveled.

Records must make it possible to reconstruct the route, identify the vehicle or service provider and handle deviations such as damage, accidents or temperature excursions.

This is the set of elements we analyze.

What we assess in transportation

Depending on the operation, the scope may include:

  • Carrier qualification
  • Subcontracting
  • Routes
  • Vehicles and equipment
  • Cleaning and maintenance
  • Environmental monitoring
  • Cold chain
  • Cargo security
  • Occurrences and deviations
  • Cross-docking and hubs
  • Traceability and records

Qualification of carriers and subcontractors

The assessment starts with the requirements the company expects from the service provider.

We can review documentation, approval criteria, contracts, occurrence records, performance and the requalification routine.

If there is subcontracting, we also analyze how it is controlled.

Routes and risk assessment

Not every route has the same conditions.

Distance, transit time, stops, climate, cargo transfers and product type can change the risk. The analysis should consider these factors before defining monitoring or a qualification study.

Temperature and humidity monitoring

When monitoring is part of the operation's controls, we assess equipment, placement, records, alarms, acceptance criteria and the handling of out-of-specification results.

Cold chain

Products that depend on a controlled range require attention from load preparation through receipt at the destination.

The scope may involve packaging, packing configuration, transit time, transfer points, monitoring and evaluation of excursions.

Vehicles, cleaning, maintenance and security

Controls must be compatible with the type of cargo and the risk of the operation.

We can review records of cleaning, maintenance, vehicle inspection, access control, security and the conditions used to accept or reject a vehicle before loading.

Accidents, damage and excursions

An occurrence must leave sufficient records for the company to understand what happened and decide the disposition of the product.

The analysis considers communication, segregation, investigation, the decision on the cargo and the actions taken to prevent recurrence when necessary.

Cross-docking, hubs and in-transit storage

Intermediate points are also part of the product's route.

Where they exist, we assess the dwell conditions, transfers, records and responsibilities defined for these stages.

Traceability and records

The company must be able to reconstruct a shipment using the available records.

In a sample, we can start from a shipment or batch and check whether it is possible to identify origin, destination, carrier, route, occurrences and other information defined in the process.

How we carry out the analysis

The work combines a review of procedures and records with interviews and, where applicable, observation of dispatch, loading, transportation or receiving steps.

The sample shows how the defined controls were applied in the selected cases.

Operational evidence

Manifests, temperature records, vehicle checklists, proof of delivery, occurrences, route reports and qualification documents may be part of the analysis, depending on the scope.

What the company can receive

  • Technical assessment
  • Review of transportation processes
  • Action plan
  • Inspection readiness
  • Support with carrier qualification
  • Support with transportation and cold chain validation

When to engage us

Before an inspection, when adding new routes or service providers, after recurring problems, during a Quality System review or when the company needs to structure its transportation process.

Frequently asked questions

Do you work with carriers and also with companies that outsource transportation?

Yes. The scope changes depending on whether the company performs the transportation itself or contracts third parties.

Is it possible to analyze a specific route?

Yes. The work can be limited to a specific route, product, service provider or process.

Does cold chain always require the same study?

No. The design depends on the product, packaging, route, time, transportation conditions and existing controls.

Want to review your transportation process?