GMP certificate confirming the competent authority of BV Cyclotron VU
Amsterdam, 18/02/18. The Health Care Inspectorate for Pharmaceutical Affairs and Medical Technology has re-issued our GMP-certificate, confirming the competent authority of BV Cyclotron VU. Our site has been inspected under the national inspection programme in connection with manufacturing authorisation no, 108669 F in accordance with Art l3 of Directive 2001l20/EC transposed in the national legislation Art. 100 of the Medicines Act.
BV Cyclotron’s CEO Erik van Lier: “We are proud that the certificate reflects the status of our manufacturing site. For our customers this means, that they can continue to rely fully on our high-quality, clinical grade production of radiopharmaceuticals and radiochemicals for medical diagnostics and research”.
Located at the campus of VU University Medical Center in Amsterdam, Cyclotron VU produces GMP- compliant medical isotopes in state-of-the-art manufacturing facilities. These products are used daily by pharmaceutical and biotechnology companies, medical device manufacturers, hospitals, clinics, and research laboratories.
The GMP-certificate approves the following:
1 Manufacturing Operations
1.1 Sterile products
1.1.1 Aseptically prepared (processing operationsfor thefollowing dosageforms)
126.96.36.199 Small volume liquids
1.1.2 Terminally Sterilised (processing operationsfor thefollowing dosageforms)
188.8.131.52 Small volume liquids
1.1.3 Batch certification
1.4 Other products or manufacturing activity
1.4.1 Manufacture of
184.108.40.206 Other: radioactive parent material(en)
1.4.2 Sterilisation of active substance/ excipients/finished product
220.127.116.11 Filtration 18.104.22.168 Moist heat
1.4.3 Other:radioactiveparent material/en)
1.6 Quality control testing
1.6.2 Microbiological: non-sterility
If you want to search for our GMP-certificate on the website of EudraGMP, please enter the certificate number: NL/H 15/1003307 2 and countryname “Netherlands”.
Download the certificate
GMP certificate Part 1
GMP certificate Part 2