Certified pharmaceutical logistics
Every service provider dealing with medicines and medical products must be certified. But there are subtle differences, for example with respect to testing institutes. Those who take this very seriously – as we do – attach importance to GMP, GSP and GDP official certification.
In addition, we have a tested quality and environmental management system as well as a manufacturing and wholesale permit.
Good practice for all services
The GMP (Good Manufacturing Practice) certificate is essential in the pharmaceutical sector, including for logistics companies – because assembly and packaging are also part of the production process. As we provide comprehensive value-added services in our customers' supply chain in the area of contract manufacturing and secondary packaging, we have been certified by the Brandenburg State Office for Occupational Safety, Protection and Health in accordance with section 13 AMG: We have a manufacturing permit and the GMP certificate. We were one of the first German service providers to the pharmaceutical industry to be awarded an official GDP (Good Distribution Practice) certificate in recognition of our compliance with the strict guidelines of the EU Commission.
In manufacturing practice, we meet the following requirements according to Section 13 AMG and GMP:
- certified quality management system
- competent and trained employees
- qualified personnel, including two pharmacists
- certified areas for quality control, assembly, packing, labelling and coding activities
- suitable equipment and facilities
- tested materials, containers and labels
- approved procedures and instructions
- suitable storage and transport (certified according to GSP and GDP)
We also pay close attention to the standards when it comes to storage und transport. The certificates for Good Storage Practice (GSP) and Good Distribution Practice (GDP) issued by the Brandenburg State Office certify the high quality of our services, as part of which we take into account the strict EU guidelines and other legal requirements.
No compromises – at UNITAX this also applies to the management systems. The ICG (International Certification Group) has certified our quality management according to DIN EN ISO 9001:2015 and our environmental management according to DIN EN ISO 14001:2015. The certificates are valid for the production (secondary packaging) and storage of pharmaceutical products, container and pallet cleaning and transport logistics.
In quality management, quality assurance and quality control are all interrelated: All the processes in the various service areas are defined in such a way that they first and foremost guarantee high product quality, ending in tested, coded items which can be traced, for example, using the data matrix code or the EDMC/"China-Code". This is how we achieve the excellent performance level that our customers value so much.
We place great value on our environmental management: In order to protect human beings and nature, we strictly adhere to all legal requirements. With detailed procedural instructions and process descriptions, we ensure that our actions always meet the requirements of sustainability and environmental compatibility.
We take over a large part of the value chain for our customers. For this reason, we as a professional and conscientious pharmaceutical logistics service provider have been granted manufacturing and wholesale authorization by the Brandenburg State Office for Occupational Safety, Consumer Protection and Health.
Prior to approval, the State Office checks during extensive audits whether all the requirements are fulfilled. These include, among other things, an audited quality management system, suitable equipment, and a qualified person. We regularly check the processes to ensure ongoing secure procedures.