Quality is no coincidence
Quality Management System
To satisfy the highest standards of quality, safety and flexibility in the pharmaceutical industry at any time, we work on the basis of a comprehensive and constantly evolving quality management system. Through qualified processes, employees and technology and a verified transport process we ensure GDP-compliance and achieve process optimization, risk minimization and continuous improvement. Our elaborated action and decision templates as well as qualified, efficient courses of action in case of failure are very helpful with that. This represents a significant contribution to the permanent maintenance of the product and process quality.
Our quality policy is based not only on its own claim but also on the needs of our customers. Each employee is aware that the success of the TRANSCO Berlin Brandenburg GmbH also depends on the quality of his personal power.
As part of a complete cold chain solution we ensure the strict compliance with the following regulations:
– The German Medicinal Products Act – The Drug Law (AMG)
– The German drug and drug substance regulation (AMWHV)
– The GDP-guideline for good distribution practice of medicinal products
– The GDP-guideline to the principles of good distribution practices for active substances of medicinal products
Thus, our quality management system is certified according to DIN EN ISO 9001:2015 and GDP. Furthermore, we regularly undergo the SQAS Assessment of Cefic. Through our Quality Management Agent (QMA), the solid assurance of quality and documentation to ensure all requirements is guaranteed.
To ensure GDP-compliant transport our quality management system includes a GDP-based risk management. Using risk analysis in terms of an FMEA, we have verified the transport process and considered all the relevant factors. So we can ensure a product-specific temperature control along the entire cold chain as well as the monitoring of all critical parameters in real time. This allows us a short-term intervention in case of deviations from the target process. The required timely documentation is ensured during the entire transport process.
In order to completely fulfill all requirements, we only employ qualified personnel and equipment. Documented training plans determine our training system, in which all employees are integrated. Each employee is trained at least twice a year by our external Qualified Person (QP) in the GDP regulations and qualifies only in passing the exam.
All vehicles used are qualified by ATP certificate, calibration and cleaning. The redundant applied temperature sensing systems for the transport are annually checked by calibrated measuring instruments and documented as well as regular cleanings. To check the vehicles, we regularly conduct vehicle inspections and document these.
Clearly formulated SOP regulate our processes and are at disposal for all employees at all times. Among other things, our CAPA / incident management is included herein. Our incident management is characterized by proactive action, since all deviations from the standard process are documented, reviewed and assessed. Any change of a process is documented in our Change Control System
The constant execution of self-inspections, in cooperation with our QP, is used to test and improve our process quality and to verify compliance with the principles and guidelines of GDP. Furthermore, we let our customers audit us on a regularly basis, work with the appropriate logs / audit reports and we ourselves lead audits at our subcontractors. All service providers shall be selected, reviewed and conducted in accordance with the requirements. A review of the subcontractor is based on self-evaluation forms and on-site audits. Only qualified subcontractors are used for TRANSCO Berlin Brandenburg GmbH. If a service provider does not render a GDP-compliant performance, he is captured on our blacklist and henceforth no longer used. This is the only way how we can ensure to achieve our own goals.
We want to offer you your tailor-made pharma service according to a GDP-compliant transport processing and implement it for you.
At TRANSCO Berlin Brandenburg GmbH we live quality. That means we meet both the ever-growing regulatory requirements (also across countries) and the increasing demands of our customers to secure cold chain in its entirety, thus providing you with a clear competitive advantage. The transport takes place in accordance with the product specification under temperature-controlled conditions.
Already today we occupy ourselves with tomorrow and continually invest in improving our service in order to respond flexibly to new requirements. We pursue this goal consistently in order to ensure the safe cold chain gaps to guarantee the product quality and thereby maximizing patient safety. We pay attention to all pharmaceutical compositions as if they were intended for us. Every employee involved in the process understands what it means to transport pharmaceuticals.
Our quality management system at a glance:
- Continuous improvement process
- Change control
- Risk management
- Professionally trained staff
- Vehicle qualification
- QMA and QP
- Temperature monitoring along the entire cold chain
- Cleaning procedures
- PEST control
- Security checks
- Emergency plan
- CAPA / Deviation management