SurveyMonkey Powered Online Survey

Dear Colleagues,

Please answer the following questions. The results of this survey will be shown in the next Maas & Peither Newsletter LOGFILE.

We will, of course, ensure absolute anonymity for our participants. Thank you very much for your willingness to participate.

With kind regards,

Thomas Peither
President

Question Title

* 1. In your opinion how does the cooperation between pharmaceutical manufacturing and technology (internal and external) work in the qualification of facilities and equipment?

very good

good

fair

bad

Question Title

* 2. Do you conduct qualifications of facilities and equipment retrospective?

Yes

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* 3. Do you utilize external assistance for the qualification of facilities and equipment?

Yes - for planning, organization and documentation.

Yes - to implement the qualification plans on the equipment.

Yes - the qualification is entirely turned over to external service providers / contractors.

No - we conduct the qualification of facilities and equipment ourselves.

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* 4. Which method of risk analysis do you apply?

FMEA (Failure Mode and Effects Analysis)

FTA (Fault Tree Analysis)

own method

other

none

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* 5. How often do you conduct requalifications?

after major modifications

after 2 years at the latest

never