SASAI – Shared Audit and Supplier Assessment Initiative
To all manufacturers of PET radiopharmaceuticals – learn here how you can make your inspectors happy and still save time and money
Regulatory authorities across Europe are increasingly and consistently requesting that each radiopharmaceutical producer should assess and document the qualification of all suppliers of starting materials, such as active pharmaceutical ingredients and precursors as well as excipients and raw materials on a regular basis. It is expected by the regulatory bodies that the manufacturer of radiopharmaceuticals should perform regular audits at least for the suppliers of critical starting materials.
Therefore, multiple institutions across Europe are being requested to perform audits on the same suppliers, usually independently and in a non-coordinated manner. In addition, radiopharmaceuticals are often manufactured by small institutions or universities that in most cases do not have the staff resources and financial means to perform these audits regularly if at all.
SASAI in a nutshell
The idea is to perform quality audits of starting material suppliers, conducted by a small team of independent, qualified auditors and to share the audit report afterward with interested parties. In order to cover the costs, a service fee will be raised.
The concept is being developed by a group of experts under the lead of the Drug Development and the Radiopharmacy Committee of the EANM.
What are my institution’s benefits?
- Save time, money & resources
- Ensure a constant high quality of your audits – conducted by independent, professional auditors, following a standardized template (with the possibility for customization)
Which kind of companies could potentially be audited?
Download the preliminary list of companies here (updated version).
What would the report look like?
Download the preliminary audit report template here.
Who is developing the concept for this project?
SASAI has been proposed and is developed under the lead of the EANM Drug Development and Radiopharmacy Committee. An international group of experts has been nominated through an open call to help in the planning and facilitation of the project. The project is approved and supported by the EANM Board who strongly believes in the potential of SASAI. Beyond the proof-of-concept audit the project management will be handled through EARL (EANM Research Ltd.)
How will I gain access to the results of the audit?
A standardized audit report, produced by independent professional auditors, will be available for interested parties at the EARL Office against a service fee.
What is the cost of the audit report?
The height of the service charge is part of the feasibility study of SASAI. Current calculations suggest a fee of up to EUR 1,500 per standard audit report.
Will my institution have the possibility to have an influence on the content of the audit?
The current concept foresees the possibility for producers to take an active influence in the audit during the planning phase (terms and conditions under development).
What are the legal implications of SASAI?
You are responsible on a national level to contact your authorities to investigate the acceptance of such a community-based audit. From the feedback that the SASAI working group was able to gather up to now, authorities highly appreciate the approach.
What is the current status of SASAI?
SASAI has been under development by the EANM since 2018 and is approaching the end of the feasibility study phase.
Whom may I address with further questions?
Feel free to contact Ms. Iva Hristova from the EARL Office via firstname.lastname@example.org for any further inquiries.