Quality Management – Introduction
PHARMACEUTICAL LOGISTICS - WITHOUT RISKS AND SIDE EFFECTS
THE QUALITY MANAGEMENT AT LAMPRECHT PHARMA LOGISTICS
SAFETY THANKS TO GMP AND GDP
As drugs and active pharmaceutical ingredients are increasingly produced abroad and travel long distances between production and the patient, the requirements for the transport, handling and storage of pharmaceutical products are constantly increasing. Although transport times in relation to the expiry dates of finished medicinal products, raw materials and auxiliaries are very short, it is precisely these short time periods that can be sufficient to permanently damage the products. And these could in return endanger the safety of the patient.
Especially because logistics processes are becoming even more complex as a result of increasing globalization, the requirements are also increasing to ensure constant quality, product integrity as well as protection against counterfeiting and constant traceability. Legislators have acted accordingly and, in addition to the GMP (Good Manufacturing Practice) Guidelines for Pharmaceutical Manufacturer’s; have also defined the GDP (Good Distribution Practice) Guidelines for all parties of the supply chain. Only a consequent implementation of these requirements results in the patient receiving a high-quality product in hospitals, at the doctor's office or in the pharmacy.
It is therefore the greatest importance that these high requirements are also met along the entire supply chain after the compliant manufacturing process of pharmaceuticals. So that means to work compliant during transport by road, air, sea, during storage at a logistics service provider or even during the brief intermediate storage in handling hubs. The consistent implementation and maintenance of GDP/GMP requirements is one of our core competences as a pharmaceutical logistics provider.
THE INTEGRATED MANAGEMENT SYSTEMS
The primary objective of Lamprecht Pharma Logistics Ltd. is thus quality assurance along the entire supply chain as well as the sustainable and ecological cooperation with partners, networks and suppliers.
Our standardised processes and risk-based operations guarantee our customers the highest quality at all levels. For this purpose, Lamprecht Pharma has implemented a solid and integrated quality management system that complies completely with the requirements of the GDP/GMP Guidelines. In addition, Lamprecht Pharma Logistics Ltd. was the first pharmaceutical logistics company in Switzerland to ever qualify for the necessary wholesale and operating licenses as well as for the following qualifications:
- ISO 9001: 2015 Certification
- GMP Certification (Swissmedic)
- GDP Certification (Swissmedic)
- Wholesale licence for storage, manufacturing, import, wholesale, export and cross trade (Swissmedic)
- Operating license for the handling of controlled substances (Swissmedic)
- Regulated Agent (FOCA - Federal Office of Civil Aviation)
- Certification as "Envirotainer Provider Advanced Level"
- IATA Registration
The consistent implementation as well as the continuous review and improvement of all relevant requirements guarantee transparency and traceability at all times - always in the interests of the patient!
EVERYTHING OUT OF ONE HAND
We offer our customers one-stop pharmaceutical services customised to the needs of our customers. Lamprecht Pharma Logistics AG commands a qualified infrastructure for storage in ambient temperature ranges, from refrigerated goods to frozen goods, narcotics and hazardous substances. The entire infrastructure at our location in Pratteln is access-protected as well as humidity and temperature monitored. Measures for absolute hygiene and cleanliness are consistently implemented.
Seamless, collaborative communication and knowledge management are the success factors in our industry. Therefore, we dispose of a comprehensive, qualified supplier pool and - as a partner of “Pharmafreight” network – we are also optimally networked to all matters concerning GMP/GDP in the warehouse, on the road, in the air and sea freight routes.
We are also pleased to offer additional value-added services to our customers. In addition to GMP activities such as repackaging, labelling of products, production of sales samples or the exchange of package inserts, these also include data logger management and passive shipper packaging - also for dry ice shipments with our own specially qualified passive shipping products. The integrated quality management and standardised processes guarantee quality at the highest level.
QUALITY POLICY AND CORPORATE CULTURE
It is not only the quality management system and the approvals and certificates behind it all, that is important to constantly protect patients against counterfeiting, interference with quality or efficiency of the drugs, but this is consistently implemented by all employees and parties along the supply chain. For this reason we invest a lot of time in the education and training of our qualified staff. The protection of our employees, especially in dealing with sensitive but predominantly chemical substances, is just as important to us. That is why we as Lamprecht Pharma Logistics Ltd. attach great importance to comprehensive health and safety at work in the Lamprecht Pharma facility. Awareness of the environment and sustainability is firmly anchored in our team and is an integral part of the cooperation with our suppliers.
Should you have any queries, please contact our Quality Management Team:
Dr. Roland Gassmann
Qualified Person FvP
D +41 61 284 77 84
D +41 61 284 77 95
D +41 61 284 77 74