Authorisation and inspection of blood establishments
Definition and benefits
During the inspection/approval procedure, the blood establishments are assessed whether they comply with the Austrian Medicines Act (AMG) and/or the Blood Safety Act (BSG) and its ordinances as well as if the facility/premises with all implemented safety measures ensure the best possible protection of donors and patients.
In the first step, the submitted application is checked for completeness. In case documents are missing or inadequate, the establishment will be notified to provide additional information. The administrative framework of the inspection procedure has to comply with the General Administrative Procedure Act (AVG).
Once the information of the application is complete, the inspector arranges an appointment for an on-site inspection with the tissue establishment. A written notice containing a rough agenda and a list of documents and information to be submitted follows this.
The on-site inspection starts with an opening discussion, in which the inspection team, management and key personnel take part. Once opened, the agenda will be consolidated and the objective and scope of the inspection clarified.
Next the tissue establishments presents itself including their quality assurance system, which already represents the beginning of the actual inspection. After having inspected the first documents, the inspection team goes on a tour in the facility. Afterwards the examination of relevant documents is continued.
At the end of the inspection, the leading inspector will summarise the observations in a final meeting for the management and key personnel and discuss the next steps of the procedure.
The observations and deviations will be summarised in an inspection report. The first version is sent to the tissue establishment for party hearing (AVG). The tissue establishment now has the opportunity to comment on this report and is obliged to submit an action plan including a timeline.
After evaluation of the company’s statements by the inspectors, the inspection result together with any authorisation or certification documents and the final report are sent to the Federal Office for Safety in Health Care (BASG).
The procedure has now been completed (AVG).
The in the following listed applications in the sense of the Austrian Medicines Act, Austrian Blood Safety Act and Austrian Tissue Safety Act are mandatory starting from 06.04.2020 in accordance with electronic submission regulation (EEVO) over the eService inspections & surveillance:
- authorisations and certificate confirmations
- inspection of a design qualification
- third country (re)inspections
- (de-) registration of brokers
- (de-) registration of responsible persons / Qualified Persons
- official certificate
From this point on, periodic inspections according to Austrian Medicines Act (GMDP, PV), Austrian Blood Safety Act and Austrian Tissue Safety Act are also handled by eService inspections & surveillance. Inspections in the area of narcotic drugs and psychotropic substances should also be handled by eService inspections & surveillance if possible. At present, deviations are possible in individual cases after consultation.
Support authorisation holder/site
Registration examples are described in the guidance note eService inspections & surveillance (only available in German)
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Guidance note eService inspections & surveillance (only available in German)
- Only available in German11/12/2017
What is subject to authorisation?
In the field of blood safety, a basic distinction is made between the authorisation/amendment laid down in the Blood Safety Act (BSG) (§ 14 (1) and (3)) and pursuant to the Austrian Medicines Act (AMG) (§ 63 and 65). The authorisation/amendment according to the BSG concerns the donation and testing of blood and blood components. The authorisation/amendment according to the AMG covers the processing, the storage and the distribution of blood and blood components.
Typical examples of amendments according to BSG: new procedure in donor testing (e.g. change of method for haemoglobin determination), relocation of donor premises.
Typical examples of amendments according to AMG: new processes in processing (e.g. introduction of pathogen inactivation), relocation of processing, laboratory and storage facilities
In Article 5(1) of Directive 2002/98/EC it is laid down that activities relating to the collection and testing of human blood and blood components, whatever their intended purpose, and to their preparation, storage, and distribution when intended for transfusion, are undertaken only by the blood establishments which have been designated, authorised, accredited or licensed by the competent authority for that purpose.
In the implementing Directive 2005/62/EC 'processing' is defined as any step in the preparation of a blood component that is carried out between the collection of blood and the issuing of a blood component.
According to the Austrian Medicines Act (AMG), human blood or blood components, which are intended to be used for transfusion, are not considered medicinal specialities, but meet the definition of medicinal product. Consequently, § 63 AMG and § 65 AMG are to be applied, also because the irradiation process has an effect on the quality of the medicinal product.
Irradiation (e.g. 3 min. / 25 Gray) prevents the growth of transfused lymphocytes in the recipient and thus the development of GvHD (Graft-versus-Host-Disease). Already 10^4 transfused cells / kg body weight of a patient can trigger GvHD (in immunosuppressed patients 10^4 and in patients without immunosuppression 10^7).
Irradiation irreversibly damages the DNA of the lymphocytes. Irradiation prevents the proliferation of lymphocytes and the colonisation of foreign clones. These foreign clones ultimately triggers the rejection reaction against the host.
Other diseases are not prevented by the irradiation, e.g. transmission of viruses or bacteria. For the purpose of pathogen inactivation, mostly additional chemical substances in combination with other types of radiation (e.g. UV) are necessary.
Most recipients are immunocompromised patients (bone marrow / blood stem cell transplant patients, patients before autologous blood stem cell collection, and patients with congenital immunodeficiency). In addition, similar to patients with leukaemia, malignant lymphomas and tumours, the blood components from first-degree relatives have to be irradiated. Furthermore, granulocyte preparations have a high content of lymphocytes and therefore are always irradiated.
Irradiation can prevent transfusion associated - GvDH by inhibiting the replication of immunocompetent cells. The functionality of thrombocytes and granulocytes is not affected by the procedure.