Your Global Pharma Logistics Specialist for temperature-sensitive API, IMP and Sample Shipments

It's T°Safe's pleasure to meet you at the upcoming Pharma Conferences! We will be participating at Temperature Controlled Logistics in Biopharmaceuticals & Clinical Trial Supply Europe (15th-16th March, 2023) in Milano. Drop us a call or an email, and allow us to introduce our beneficial cost saving solutions!

T°Safe Quality Management

Good Distribution Practice and DIN ISO 9001:2015

T°Safe’s GDP (Good Distribution Practice) set-up and general GxP compliance is the key for biopharmaceutical customers. T°Safe is committed to quality, constantly checking and reviewing it’s own processes.
This not only applies to the core area but also for all outsoured processes with our global network, stations and handling partners.

T°Safe’s quality management system is GDP compliant, thus conforms to the highest standards and adheres to the rigorous international standards.

In the course of quality assurance, our information system iDEX measures all the relevant key performance indicators (KPIs) and is subject to regular external assessments (customer audits).

Find more information about the TSafe services, the quality management system and certificates in the information section.

GDP Guidelines for Medicinal Products for Human Use

Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (Text with EEA relevance) 2013/C 343/01

GDP Guidelines for Active Substances for Medicinal Products

Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use (Text with EEA relevance) (2015/C 95/01)

GxP

GxP is a general term for Good (Anything) Practice quality guidelines and regulations. These guidelines are used in many fields, including the pharmaceutical and food industries.
The titles of these good practice guidelines usually begin with “Good” and end in “Practice”, with the specific practice descriptor in between. GxP represents the abbreviations of these titles, where x (a common symbol for a variable) represents the specific descriptor.
A “c” or “C” is sometimes added to the front of the initialism. The preceding “c” stands for “current.” For example, cGMP is an acronym for “current Good Manufacturing Practices”. The term GxP is frequently used to refer in a general way to a collection of quality guidelines.
Source: http://en.wikipedia.org/wiki/GxP