To all manufacturers of PET radiopharmaceuticals – learn how you can make your inspectors happy and still save time and money

 Background information

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 afterwards with interested parties. In order to cover the costs, a service fee will be charged. The concept has been developed by a group of experts under the lead of the Radiopharmacy and Drug Development Committees of the EANM.

First SASAI audit report is available now

ABX advanced biochemical compounds GmbH (Germany)

To place an order for the SASAI audit report simply download, complete the audit report order form , and remit it via email to earl@eanm.org.
Take a peek at the sample report here. The appendices include a detailed review of the manufacturing process and the quality control of different products. This was verified at a batch example.

Full reports available for purchase:

• General GMP part (to order additional product reports, the General GMP part needs to be purchased as well)
• Mannose Triflate bulk
• Hardware kit for the GE TRACERlab® MX Synthesizer for F-PSMA
• Reagent-Hardware Kit for [68Ga]Ga-PSMA-11
• Precursor for [68Ga]Ga-PSMA-11
• Sterile closed glass vials
• Precursor for FET

As a prerequisite for purchasing all or some parts of the ABX report, EARL has to obtain a preapproval from ABX. Your order will be confirmed within 14 days at the latest. Upon the ABX’s approval, we will send you an agreement to be signed by a legally authorized person at your institution. Then remit it back to EARL via email for counter signature and EARL will issue an invoice. Fees are payable by bank transfer only and free from any bank or currency exchange charges for EARL. Upon successful receipt of the bank transfer, within 3 working days, EARL will send you the purchased report part of the ABX audit electronically. Please note that ABX approves only audit reports for products that have been previously purchased from ABX.

 SASAI FAQs

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 do the reports 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. The project management is handled through EARL (EANM Research Ltd.), a full EANM subsidiary.

How will I gain access to the results of the audit?

A standardized audit report, produced by independent professional auditors, is available for interested parties at the EARL Office against a service fee. Download and complete the corresponding audit report order form (see above), and remit it via email to earl@eanm.org to place your order.

What is the cost of the audit report?

The cost for the currently available reports can be found in the corresponding audit report order form (see above).

Will my institution have the possibility to have an influence on the content of the audit?

To comply with legal regulations a possibility for producers is foreseen to take an active influence in the audit during the planning phase. Once the period for contributions is closed, interested parties may still purchase the report.

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 has now completed its feasibility study phase by completing the proof of concept audit at ABX GmbH. Further audits are under development.

Whom may I address with further questions?

For further inquiries, please contact Ms. Iva Hristova from the EARL Office via earl@eanm.org.