iBET continues its our goal for strategic growth towards future challenges

24.07.2013

The Analytical Services Unit, a joint department of iBET and ITQB-UNL under the
executive management of iBET, has been granted a Manufacturer Authorization from
INFARMED that
allows it to further extend its scope of activities to quality control and lot
release of active pharmaceutical ingredients (APIs), namely human medicinal and
human investigational medicinal products.

The authorization falls under the Art. 40 of Directive
2001/83/EC and Art. 13 of Directive 2001/20/EC, or Good Manufacturing Practices (GMP) and comprises:

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 Systemof major importance for
the Pharmaceutical and Biopharmaceutical industries. Other services provided by
ASU include the development, optimization and validation of analytical methods
as well as support in Biopharmaceutical Development.

The maintenance of 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.