Saatja: <
[email protected]>
Saadetud: 03.01.2023 11:55
Adressaat: <
[email protected]>
Koopia: VAN DER SPIEGEL Stefaan <
[email protected]>;
Brusselmans Tom <
[email protected]>
Teema: PMF inspection questions - call for extra inspectors
Manused: image002.jpg
Dear colleagues, dear competent authorities on 3rd countries plasma collection sites
As you probably are aware, many 3rd country plasma collection centres (mainly US, Turkey) provide
plasma to the EU/EEA to be further used as starting materials in the manufacture of medicinal products.
These 3rd country centres need to comply with the EU Blood Directive (for the collection and testing)
and the EU GMP guidelines (for the first processing steps i.e. freezing and transport). Verifying this
requires inspections against these blood and pharma provisions.
Currently, only 4 national competent authorities are involved in these inspections: AT, DE, ES, HU.
In the last year, a high number of inspection requests was received and the current resources are not
enough to perform all the required inspections.
We therefore are actively looking for more authorities who would be willing to perform these 3rd
country inspection of blood collection centres.
These inspections are normally performed in tours of 5 – 7 blood establishments (corporate offices,
laboratories, warehouses, plasma centres, whole blood collection sites) which are in most cases
belonging to the same PMF holder but not necessarily the same parent company. The blood
establishments (BE) are grouped in tours taking into account several factors including their location to
facilitate logistics. Participating in such inspection programme typically requires blood establishment
inspection qualification, knowledge of the relevant European regulations and guidelines including the
Good Practice Guide and is supported with national training programmes and joint inspections with
other NCA’s. The inspection team performing each tour consists of at least 2 qualified blood inspectors
or at least 1 qualified inspector and 1 inspector in training. An inspection tour takes 2-3 weeks
depending on the numbers and complexity of blood establishments inspected during the tour and the
size of the inspection team. The time spent at each site is determined by various factors including but
not limited to the size and activities performed by the facility (BE I, BE II or BE III). On average, 1.5 days
are allocated for each source plasma collection centre. The EMA reporting deadline for the final reports
(one report/site) is 12 months from the day of inspection. EMA supports the trips with the NCA and
PMF-holder fee payment process.
If you would be interested, we kindly ask you to send your interest to
[email protected] by 16
January 2023.
If you have more questions, please contact
[email protected].
With kind regards,
On behalf of the EMA colleagues and the SoHO team.
European Commission
DG SANTE (Health and Food Safety)
Unit D2 – Medical Products: quality, safety, innovation
Office address: Rue Breydel 2, 06/004, B-1049 Brussels/Belgium
http://ec.europa.eu/health/blood_tissues_organs/policy/index_en.htm