Strong know-how of 25 years in the health
sector, ROXLOR provideq to his/her/its partners a
product and a service of high quality. A team, an
industrial tool, of the procedures and a control is in
place with only one objective:
THE QUALITY, essential asset to make bring
a new first-class supplier in the capsule
market.
A Quality Insurance
system has been set up to be preventive and not curative. In
accordance with the article L. 5331-1 of the code of the
public health, the company is submitted to the control
of the agency French of Sanitary Security of the Health
Products (AFSSAPS). We work according to our manual quality,
in conformity with the BPF norms (GMP) and ISO.
We are also FDA
approved. Our DMF number is 14656.
Our raw materials and
our capsules are submitted to a systematic control in our QC
laboratory. At the time of every delivery, we require a
veterinary certificate and a bulletin of analyses attesting a
complete conformity to the texts of the European Pharmacopeia
and in particular concerning the relative precautions in the
BSE.
We also provide to our
customers for every delivery a bulletin of physico-chemical
and bacteriological analyses in conformity with the
requirements of the European Pharmacopeia.
Gelatin
In spite of the
absence of transmission risk of the BSE by vector gelatin, of
makes him extreme conditions of his/her/its extraction process
even (pH - temperature), we constantly conform to the new
European instructions to guarantee you a sure
product.
Our requirements
follow the evolution of the regulation and we are held aware
of their modifications, in particular those concerning the
relative precautions to the products including a transmission
risk of agents BSE.
Lately, following the two resolutions
adopted by the Committee of Public Health of the Council of
Europe AP-CSP (99) 10.12.99 and AP-CSP (99) 22.12.99
structural on the application of the guideline 1999/82/CE"
Setting up of a process of certification of the products of
animal origin including some risks of is ", we asked our
suppliers to make the necessary steps to provide us gelatin
benefitting from a
conformity certificate to the European
Pharmacopeia.
Since 1999,
ROXLOR has decided no longer to use bones in the gelatin and
we have chosen to use only the skin (either for bovin gelatin
and for fish gelatin).
Our plant in
conformity with the regulation of April 15, 2001 fixing the
sanitary conditions for the preparation of gelatin destined to
the human consumption. We apply this regulation, even for
the capsules destined to the pharmaceutical industry, which is
not YET concerned with this regulation.
