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SASAI: Audit of CUP (June 8th-9th 2022)

In order to comply with the EU GMP guideline on outsourced activities, EARL provides you as a manufacturer of radiopharmaceuticals with the possibility to influence the design of the audit procedure, and its contents . To do this, please fill and sign the survey below.

Please note: the audit team will take the specific points proposed by you into consideration, and will audit the specific company services as extensive as possible. The SASAI audit team will evaluate all received feedback, and will create the final report.

Introduction of CUP

The SASAI initiative plans to audit the analytical service provider CUP Laboratorien Dr. Freitag GmbH, located at Carl-Eschebach-Strasse 7, 01454 Radeberg, Germany on June 8th and 9th.

CUP was incorporated in 1991. The company provides a quality management system based on GMP, which has been certified by the german authority, and are accredited as testing laboratory against DIN ISO 17025.

CUP offers microbiological, chemical and physical analysis according to the methods prescribed by the European Pharmacopoeia.

Amongst them are:

· Sterility testing of radiopharmaceuticals

· Microbial enumeration tests

· Test for specified micro-organisms

· Bacterial endotoxin tests

· Chromatographical tests (HPLC, GC, TLC)

· Spectroscopical test (Uv, IR, MS, AES, AAS)

For additional chemical or physical tests details please see:

https://www.cup-freitag.de/en/pharma/chemical-physical-analyses

Please provide the following information in English

First Name

Last Name

Email Address

Insititution Name

Country

Proposal for changes to the audit contents:

(please provide detailed description)

Please select the services of interest:

Microbiological analysis

Chemical analysis

Physical analysis

Other (please specify):