Premises and Equipment Qualification

Premises and Equipment Qualification are an essential part of the temperature sensitive supply chain & quality assurance system to demonstrate that a site, the processes and equipment are suitable for purpose and the intended use.

GCCS experts and engineers provide GMP qualifications services for:

  • The site – Warehouse and temperature-controlled areas.
  • The equipment – Refrigerated systems, trucks and vehicles.
    We use state of the art technology and a comprehensive range of unique tools – including WHO-UNICEF qualified temperature recorders, to collect data without breaking seals on packaging containers, trucks or trailers.
  • The systems – Temperature monitoring equipment.
  • The packaging – Temperature-controlled shippers.
Premises and Equipment Qualification, Photo by Adrian Sulyok on Unsplash

We can assist on all stages of the qualification process and documentation for:

  • DQ (Design Qualification)
  • IQ (Installation Qualification)
  • OQ (Operational Qualification)
  • PQ (Performance Qualification)
  • OQ and PQ Include temperature mapping for winter & summer

GCCS offer the largest range of qualification and testing services globally for GxP compliance.

Premises and Equipment Qualification and Validation processes are essential parts of GMP quality assurance systems. It must demonstrate that the site, equipment and packaging are suitable for the intended use, and guarantee that the quality and integrity of the product is maintained during storage and transport.

Temperature Thermal Mapping

Temperature mapping is effectively a heat distribution study and performed to identify if required temperatures have been attained throughout the storage area (warehouse, cool room, freezer, vaults, fridges, truck, van, containers and aircraft).

GCCS conducts temperature mapping studies globally as part of our Qualification of Premises/Equipment Qualification services. We provide compliance documentation (protocol, data collection and comprehensive report) aligned with local and global regulations and to demonstrate that all controlled storage equipment or storage areas stay within the specified limits during peak summer and winter conditions.

Contact us for more information.