iBET's Analytical Services Unit is now GMP certified

18.07.2013

iBET got its Manufacturer
Authorisation from INFARMED on July the 5th, 2013. This
authorisation was granted to the Analytical Services Unit (ASU) under the Art.
40 of Directive 2001/83/EC and Art. 13 of Directive 2001/20/EC, or Godd
Manufacturing Practices (GMP) .

The scope of the
authorisation is for Human Medicinal Products and Human
Investigational Medicinal products, namely for:

·
Non-sterile products

a)
Batch certification

·
Biological medicinal products

a)
Immunological products

b)
Cell therapy products

c)
Gene therapy products

d)
Biotechnology products

·
Quality Control Testing

a)
Microbiological: non-sterility

b)
Chemical/Physical

c)
Biological

ASU
is therefore maintaining a certified Quality Management System of major
importance for the pharmaceutical and biopharmaceutical industries and can now perform
quality control and lot release for the above mentioned types of products.

The
maintenance of a certified Quality Management System is demonstrative of ASU
commitment to Quality and therefore of benefit also for other ASU clients such
as those from the agro-food and chemical industries or academia.