Saatja: <
[email protected]>
Saadetud: 01.02.2023 10:21
Adressaat: <
[email protected]>; Brusselmans Tom
<
[email protected]>
Koopia: <
[email protected]>
Teema: Risk-based approach + sampling exercise in EU and 3rd countries
Dear colleagues, dear competent authorities on 3rd countries plasma
collection sites,
Currently, the Plasma Master File (PMF) assessors face specific problems
related to the in the PMF submitted information on blood establishments
inspections. This unclear or incomplete information sometimes leads to
delays on certification and might impact plasma approval and supply. We
therefore wanted to have your view on some current practices and future
considerations:
1) As you are aware, EMA implemented a risk based approach for Plasma
Master File (PMF) listed sites. This approach was first implemented for
third country blood establishments, but each blood competent authority
could also use this approach for the inspection of national blood
establishments and blood banks to demonstrate compliance with Directive
2002/98/EC.
Can you please inform us what the current practice is in your country?
Are you applying a risk-based approach when inspecting blood
establishments? And if yes, what are the maximum time intervals you use
for inspections of the different types of blood establishments?
2) Given that plasma collection centres are part of the same company and
they all apply the same quality system, is it acceptable in your country
to do some kind of sampling exercise when inspecting these centres? This
means instead of inspecting all centres, only inspecting the parent
organisation and a selection of some collection sites to inspect as a
sample.
3) Would you consider the sampling exercise as mentioned above also
acceptable for sites in 3rd countries?
We would appreciate if you could send your replies on these questions to
by 15 February 2023.
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, innovationOffice address: Rue
Breydel 2, 06/004, B-1049 Brussels/Belgium