Quality is one of the basic principles on which our company is based. Representing one of the most prestigious companies in the pharmaceutical sector since our very inception, we have grown, collaborating with our partners who share our vision of manufacturing pharmaceutical raw materials.
The pharmaceutical sector is an area which is subject to an ever-increasing amount of regulation. With the approval of the Directives of 19 March 2015 on the correct practices for distribution of active ingredients for medical products for human use, not only has the manufacture of raw materials been regulated, but now their distribution is also regulated. At Globalk Química, we have an integrated quality-control system, ensuring that we abide by these regulations, with a great focus placed on the supply chain process.
- We guarantee complete traceability from the original provider to our clients. We work with European manufacturers who meet the GMP regulations (for active ingredients), and IPEC GMP regulations (for excipients).
- Transport is carried out by companies specialised in the pharmaceutical industry, under GDP conditions:
- We ensure storage conditions of the raw materials are maintained for the entire duration of transportation (transport between 2-8°C or 10-25°C)
- Quality controls on transport through sending of blind testers over the course of the entire year.
- Validation of the transport routes.
- We are periodically audited by the companies we represent as part of a process of continuous improvement.
We are certified to Good Distribution Practices standards according to Guidelines 2015/C 95/01 by Spanish Health Authorities. This certification covers the GDPs activities of Globalk Química, including:
- Storage of row materials: Qualified warehouse where APis are storage under temperature controlled conditions < 25°C and between 2 y 8 °C.
- Transport of raw materials according to GDPs guidelines.
- Management of the quality systems: Customer complaints, deviations, training, computerized system validation, stock, product returns…
- GLOBALK QUÍMICA GDP CERTIFICATION BY SPANISH HEALTH AUTHORITIES (Show certificate)