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Attainment of the permit according to §20b and §20c AMG

Attainment of the permit according to §20b and §20c AMG at a fertility clinic

AVANTALION supported a fertility clinic in the reconstruction of its clean room and the necessary qualification of the rooms and instruments. Furthermore, we assisted in the validation of processes and clinic expansion by providing process optimization and the creation of a process management system.

COMPETENCIES

Business Process Management

Project Management

Qualification & Validation

Quality Management

Cleanroom Technology

Project Objectives

The adequacy of all rooms, instruments and methods had to be proven, in order to receive the permit.

The conception of the rooms and the ventilation systems as well as the re-development of processes was necessary.

Furthermore, all instruments and equipment had to be qualified and the processes and methods validated.

Our Contribution

AVANTALION lead the project and ensured the receipt of the accreditation of the fertility clinic.

AVANTALION consultants and selected pharmaceutical experts in AVANTALION’s network supported all necessary tasks in regards to content to receive the permit.

Results

As a result, the fertility clinic received the permit according to §20b and §20c AMG.

A process oriented QM system was developed and implemented.

Do you have questions about your project? We are happy to advise you:+49 6721 49 5141 - 0

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