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Biomap has developed a complimentary suite of services specifically to support the requirements of the Pharmaceutical industry in the areas of temperature compliance (cGxP).

Biomap provides project management, training, support services, Cold Chain Compliance, 3rd Party consultancy and compliant Supply Chain Services.

Biomaps
temperature mapping service is a full solution offered to map a wide range of storage and transport environments. Regulatory guidelines demand that environments such as Warehouses, Cabinets, Cold Stores and Vehicles are all regularly mapped. The mapping service also documents justification of the position of where continuous monitoring probes should be positioned.

With the increasing number of temperature sensitive products on the market, companies are regularly reviewing their shipping and packaging methods. Biomap offers a comprehensive
Packaging qualification and Route Qualification service to support clients with these demands.

Packaging qualification projects can be for any packaging method and can include temperature and humidity exposure tests as well as vibration and impact tests to simulate worst case shipping scenarios. Winter and Summer profiles are designed to meet the specific environments a particular shipping lane will be subject to during transit.

A
Route Qualification project documents the temperatures a product is exposed to during transit and can help illustrate trends through certain lanes. There may have been a number of excursions that have already been experienced and need further investigation or there may be plans for a new shipping lane with no data. Projects are tailored to meet individual client objectives and goals.

In addition to the above services Biomap also offers bespoke
Cold Chain Compliance (3CS) packages. The service is completely flexible but typically involves a detailed supply chain process map and audit. For such a comprehensive service Biomap formed a strategic alliance with one if the industries most experienced GMP consultancies, Tabriz Consulting Ltd.
Based upon the gap analysis work
Tabriz Consulting Ltd recommend mitigation plans for each risk and the work that will be involved in working towards requieed cGxP compliance.

Projects are valuable to tighten compliance in areas of weakness as well as helping to prepare for license applications or regulatory & QA audits.

Biomap also offer compliant
GDP Supply Chain Services.  This service offers flexible or long term storage and distribution services from a fully qualified 3rd party Warehouse in the South of England, ideally situated for the major airport, road and ferry transport links.  This service is a natural extension to our existing portfolio of services. 

Contact us for a no obligation chat to discuss the service further