HeX GROUP recognized GMP/BPF
Since the announcement on June 20, 2020 that the BELAC accreditations would be withdrawn following differences with the competent BELAC authority. Taking effect on January 1, 2021, HeX and all its colleagues have had to reassure customers and prospects that its quality management system will be maintained.
The genesis of this “control” department in 2005 naturally stems from the need to provide a QUALITY service.
It was therefore logical that ISO 17000 standards should form the basis of the management system. In particular, ISO 17025 for testing, calibration and analysis laboratories.
In fact, since 2011 and the first ISO 17025 and ISO 17020 accreditations, HeX will be able to boast, in January 2020, a testing scope in the cleanroom field. This is the most extensive testing scope in Europe, with almost 40 specialized ISO 17025-accredited tests.
As the HeX Group renews its accreditations in January 2020 for a further 5 years, the loss of confidence in the competent authority BELAC is growing. This led HeX to publicly announce on June 20, 2020, the voluntary relinquishment of its accreditations with effect from January 1, 2021.
HeX Group’s declared determination to maintain ISO 17000 standards as the framework for its organizations naturally led it to organize an external audit with recognized experts in early 2021. Their conclusions, following several days of visits, confirm the quality of HeX’s services.
What’s more, the construction of a new laboratory at HeX LAB in October 2020, with its state-of-the-art, fully-connected infrastructure for drug-related matrices, will further accelerate the HeX Group’s evolution towards pharmaceutical industry GMP/BPF standards.
HeX: an ongoing commitment to quality
As of January 2021, HeX is working to meet euGMP requirements in order to receive inspection from the Belgian Federal Agency for Medicines and Health Products in June 2021.
8 October 2021
is officially recognized by GMP/BPF
and in particular the quality control of microbiological drug products.
In addition, this recognition is part of HeX’s ongoing commitment to offering its customers ever greater guarantees of quality. Moreover, these GMP requirements are also in line with the continuity expected of HeX customers, whether industrial, biotech or hospital-based, to meet the same levels of GMP requirements they have to satisfy.
Thank you everybody!
HeX GROUP and all of its employees are proud to continue in their quest for quality
while building genuine partnerships with our customers, with the aim of creating a win-win synergy for all parties.
Finally, would you like more information about our GMP accreditation and/or our quality management system?