Quality and safety

VTS specializes in temperature-controlled transport, logistics and handling of medicines in its broadest sense; medicines for human or veterinary use, medical devices, APIs (Active Pharmaceutical Ingredients) and Opiates. While performing our services product safety and temperature control are always very important so that we can meet the high quality and temperature requirements of the pharmaceutical industry.

Quality throughout the supply chain

As a logistics service provider we serve the complete supply chain. While performing our services, we monitor the temperature and quality 24/7. In addition to our validated fleet, state-of-the-art warehouses and latest IT systems, the quality is supported by several other aspects:

kwaliteit en veiligheid vts transport en logistics

Risk Management 

Change management and control with online revision and status control

Qualification and validation protocols

Annually qualification of equipment and processes

Risk assessments at (sub)contractors

Quality department

Central department within VTS

Quality control

3 Responsible Persons & 1 Qualified Person

In-house knowledge

Audits

Multiple audits by national Authorities

Multiple audits by customers (25-30 per year)

Audits by notified bodies

QMS

Web based software with document management

Daily updated by quality Department

Compliance –, incident complaints –, process and risk management

Operations and measurement standards (SOP, CAPA, KPI)

Temperature-controlled

Real time temperature monitoring and surveillance of warehouses

Real time temperature monitoring and surveillance with GPS of transport vehicles

Temperature report per shipment start to end

Validated warehouses/ fleet and calibrated temperature sensors

Personnel

In-house (re)training of personnel

GDP E-learning personnel

Central registration of personnel with current certificates and expiry date of certificates

Specialized employees always act quickly and accurately on temperature alarms (when they occur)

Certifications

VTS has obtained various certificates:

ISO 9001:2015
All VTS activities are ISO 9001:2015 certified. ISO 9001 is an international standard for quality management. With this certification, we show that we are able to meet customer requirements, applicable laws and regulations and the requirements of the organization itself.

ISO 13485
The ISO 13485 standard ensures European harmonization of the regulations for the quality during transport and storage of medical devices. By obtaining this certificate, we demonstrate that our services (transport and storage) meet the requirements of our customers and the legal requirements that apply to medical devices.

Wholesale license
The wholesale license is mandatory for the supply of medicines that have been imported within the EEA (European Economic Area; the EU Member States plus Norway, Iceland and Liechtenstein). With this license, medicines may be stored at VTS for longer than 72 hours.

GDP-certificate
The GDP certificate stands for ‘Good Distribution Practice’. After inspection by the ‘Inspectie Gezondheidszorg en Jeugd (IGJ)’, we have obtained the GDP certificate. The confirmation that the product safety and quality of medicines are consistently guaranteed at VTS.

Manufacturing and Import License (MIA) and GMP
The Manufacturing and Import License (MIA) is for companies involved in manufacturing and/ or importation activities for medicines (importing means sourcing medicines from outside the EEA (European Economic Area; the EU Member States plus Norway, Iceland and Liechtenstein). Good Manufacturing Practices (GMP) is a quality assurance system for the human and veterinary pharmaceutical industry. We have obtained both the MIA license for secondary packaging and import of pharmaceutical products as the GMP certificate.

TAPA TSR en FSR
TAPA’s Trucking Security Requirements (TSR) are designed to protect products transported by road and improve driver and vehicle safety. The TSR specifies the minimum acceptable security standard and the methods to be used to maintain those standards. The Facility Security Requirements (FSR) help protect theft-sensitive products that are stored or processed in, for example, warehouses and distribution centers. Part of our fleet is TAPA-TSR level 1 certified, the highest level for the safe transport of your valuable products.

AEO-C customs simplifications
This is a license to simplify Customs procedures. By obtaining this license, our clients and we are entitled to a number of legal facilities and associated benefits, such as fewer physical checks and priority at custom checks.

Customs depot
In our warehouse we have a customs warehouse where goods from outside the EU can be stored. No import duties are due on this.

Opium Exemption
We have a temperature-controlled safe for the safe storage of opiates and we have an Opium exemption for category 1 products. This allows us to store all medicines that fall under the Opium Act. 

Quality and safety at VTS

Thanks to the various certifications, our specialized and trained employees and years of experience, we can guarantee the quality and safety of your products. Would you like to know more about the quality and safety of our services?

Contact us
Contact us +31 (0)485 - 575 354