Services

Qualification

Our mostly used qualification services are also accreditated by NAH (the Hungarian Accreditation Authority) and comply with the ISO 17025:2005 standard.

Annex of specification

  • temperature distribution test
  • humidity distribution test
  • cleanroom particles count test

We provide full qualification service, including working out protocols; giving the method of the needed tests; collecting the references needed for definition of the user’s requirements.

Furthermore we make qualification tests on the basis of the test plans, and record the results. After evaluation – with making qualification report and adding the necessary attachments – we hand a complete documentation to our Partners which are presentable in case of audits.

During working out documentation we are ready to create a special form in accordance with the Partner’s requirements on the basis of internal methods, instructions, templates.

In several cases we take part in the qualification work of the installed equipment as the producer-vendor’s partner.

We cooperate with our Partners as members of the qualification team, and we can help avoiding the known mistakes during the working procedure.

Our colleague’s’ high level preparation and knowledge guarantees that our tasks are done in the most consummate way.

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References

Egis Pharmaceuticals PLCBudapest, Körmend
Egis Pharmaceuticals PLC
Meditop Pharmaceutical Ltd.Pilisborosjenő
Meditop Pharmaceutical Ltd.
Sauflon CL Ltd.Gyál
Sauflon CL Ltd.
Sanofi-Aventis Chinoin Plc.Budapest, Miskolc-Csanyikvölgy
Sanofi-Aventis Chinoin Plc.
Mylan Hungary Ltd.Komárom
Mylan Hungary Ltd.
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